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December 19, 2016 Update to the Update Bidding Process for “Date Certain M&A” of Rio Grande Neurosciences, Inc., its Assets and Intellectual Property

Posted in Uncategorized, tagged , , , , , on December 19, 2016| Leave a Comment »

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The Bidding Process, Procedures for the Sale of certain Assets and Intellectual Property of Rio Grande Neurosciences, Inc.

Further to Gerbsman Partners sales letter of December 13, 2016 regarding the sale of certain assets of Rio Grande Neurosciences, Inc.. (“RGN”), I am attaching the Asset Purchase Agreement (“APA”) that is required with any bid, for interested parties bidding on the assets and IP of RGN. Also, I am attaching an “Executive Summary” that supplements the detailed information in the sales letter you have received and an updated “NDA” (Exhibit A).

Ken, Dennis and I will be following up to review the Bidding Process, schedule due diligence meetings and answer any questions regarding the “Date Certain M&A Process”.

Gerbsman Partners has been retained by RGN to solicit interest for the acquisition of part or substantially all of RGN’s assets, including its Intellectual Property (“IP”), in whole or in part (collectively, the “RGN Assets”).

Any and all the assets of RGN will be sold on an “as is, where is” basis and will be subject to “The Bidding Process for Interested Buyers”, outlined below.

Prior to the bid date of January 24, 2017, I would encourage all interested parties to have their counsel speak with Anthony A. Adler, Esq. of Mitchell Silberberg & Knupp aaa@msk.com at 310 312 3186– regarding reviewing and negotiating the attached “APA”. He is available to discuss any questions or comments of a legal nature relating to the transactions contemplated by the “APA”.

IMPORTANT LEGAL NOTICE

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to RGN’s Assets has been supplied by RGN. It has not been independently investigated or verified by Gerbsman Partners or their respective agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.

Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of RGN’s or Gerbsman Partners’ negligence or otherwise.

Any sale of the RGN Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of RGN and Gerbsman Partners. Without limiting the generality of the foregoing, RGN and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the RGN Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the non-disclosure agreement attached hereto as Exhibit A.

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a Confidential Disclosure Agreement (attached hereto as Appendix A) to have access to key members of management and intellectual capital teams and the due diligence “war room” documentation (“Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has had an opportunity to inspect and examine the RGN Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and Gerbsman Partners (and their respective staff, agents, or attorneys) do not make any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the RGN Assets. Each sealed bid must be submitted so that it is received by Gerbsman Partners no later than Monday, January 24, 2017 at 3:00pm Pacific Standard Time (the “Bid Deadline”) at 211 Laurel Grove Avenue, Kentfield, CA 94904. Please also email steve@gerbsmanpartners.com with any bid.

Bids should identify those assets being tendered for in an identifiable way. Specifically, RGN’s three core assets, multicoil transcranial magnetic stimulation, pulsed electromagnetic field technology, and closed-loop transcranial electrical stimulation platform, can be bid on in whole or in part.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase. All bids must be accompanied by a refundable deposit in the amount of $200,000 (payable Rio Grande Neurosciences, Inc.). The deposit information will be supplied in the next “update”.  The winning bidder will be notified within 3 business days of the Bid Deadline.  Unsuccessful bidders will have their deposit returned to them within 3 business days of notification that they are an unsuccessful bidder.

RGN reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest and best bid submitted will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.

RGN will require the successful bidder to close within a 7 day period. Any or all of the assets of RGN will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the RGN Assets shall be the sole responsibility of the successful bidder and shall be paid to RGN at the closing of each transaction.

For additional information, please see below and/or contact:

Steven R. Gerbsman
Gerbsman Partners
(415) 456-0628
steve@gerbsmanpartners.com

Kenneth Hardesty
Gerbsman Partners
(408) 591-7528
ken@gerbsmanpartners.com

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Date Certain M&A of Rio Grande Neuroscience, Inc., its Assets and Intellectual Property – Gerbsman Partners

Posted in Uncategorized, tagged , , , , , , on December 12, 2016| Leave a Comment »

SALE OF Rio Grande Neuroscience, Inc.

Gerbsman Partners (www.gerbsmanpartners.com) has been retained by Rio Grande Neurosciences, Inc. (RGN) (www.RioGrandeNeurosciences.com) to solicit interest for the acquisition of all, or substantially all of, RGN’s assets.

Headquartered in Santa Fe, New Mexico, RGN is a medical device company that has developed a suite of non-invasive brain stimulation (NIBS) technologies for use in treating neurological and psychiatric conditions and enhancing cognitive performance. RGN has raised $6.2 million over 5 years of capital financing. Over $50 million has been invested into the development of these three technologies over time by RGN and predecessor companies ($20 MM invested through Ivivi Health Sciences and $30 MM invested in Cervel Neurotech, both companies acquired by RGN).

IMPORTANT LEGAL NOTICE:

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to RGN’s Assets (as defined herein) has been supplied by RGN. It has not been independently investigated or verified by Gerbsman Partners or their respective agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.

Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of RGN’s or Gerbsman Partners’ negligence or otherwise.

Any sale of the RGN Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either expressed or implied, of any kind, nature, or type whatsoever from, or on behalf of RGN and Gerbsman Partners. Without limiting the generality of the foregoing, RGN and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the RGN Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the Confidential Disclosure Agreement attached hereto as Appendix A.

Company Profile

Rio Grande Neurosciences, Inc. (RGN), a Santa Fe, New Mexico based medical device company, has developed a suite of non-invasive brain stimulation (NIBS) technologies for use in treating neurological and psychiatric conditions and enhancing cognitive performance. The NIBS technologies, also called electroceuticalsTM, include a multicoil transcranial magnetic stimulation (mcTMS) device, a radio-frequency pulsed electromagnetic field (PEMF) technology, and a closed-loop transcranial electrical stimulation (clTES) platform. Each device delivers energy to the central nervous system (CNS) differently and has been studied for different clinical and consumer applications.

Multi-coil TMS, IP from Stanford University and originally developed by Cervel Neurotech, involves selectively modulating brain circuit nodes. This is accomplished with an array of coils that steer induced electrical currents so as to optimally modulate targeted brain regions. Each magnetic coil is independently positioned and powered, thereby steering the electrical current toward unique brain areas not reachable by single-coil devices. RGN’s mcTMS assets include a sought-after intellectual property position for TMS with multiple coils and strong clinical data in the areas of depression and pain. FDA 510k clearance for treatment-resistant depression is expected in Q1 2017.

RGN’s PEMF technology is a portable treatment that inductively delivers a low-power electric field to underlying tissue. PEMF is a Class II FDA-cleared treatment for postoperative pain and edema and in randomized controlled clinical studies has been found to be safe and able to significantly reduce pain, narcotic pain medication use, edema, and inflammatory cytokine production. RGN has repurposed PEMF for treating mild traumatic brain injury and multiple sclerosis, based on studies demonstrating its anti-neuroinflammatory and neuroprotective effects. Preliminary clinical data (Harvard University) indicate that at-home treatment with the PEMF TheraCapTM reduces symptoms in patients with post-concussion syndrome.

The clTES platform has been shown to markedly enhance learning and memory. It includes a proprietary stimulator (NeuroMod16) and electrodes that can deliver conventional (tDCS, tACS, tRNS) or non-conventional (user-specified) waveforms in open or closed-loop systems that are responsive to neurological or physiological events. Each of the 16 channels operates independently in terms of frequency, amplitude, latency, and duration of stimulation. The NeuroMod16 is the only device available with these advanced capabilities.

Founded in 2011 as a start-up company with support from a Los Alamos National Labs (LANL) Venture Accelerator award, RGN has raised $6.2 million over 5 years of capital financing. Over $50 million has been invested into the development of these three technologies over time by RGN and other companies.

RGN’s mission is to address unmet needs in neurology and psychiatry as well as enhance human performance by implementing the NIBS devices described. In the near term, RGN’s technologies are oriented towards populations with depression, pain, brain injury, and multiple sclerosis; very large multibillion dollar markets.

RGN believes its assets are attractive for a number of reasons:

mcTMS

1. RGN’s intellectual property position for mcTMS covers the use of TMS with more than one coil, a position sought by single-coil TMS manufacturers.

2. mcTMS has advantages over single coil TMS, such as the ability to target multiple brain regions simultaneously or in sequence and to steer current to brain areas not addressable by single-coil approaches (e.g., deeper brain structures)

3. mcTMS has been shown to significantly reduce treatment resistant depression and a FDA 510k clearance for that indication is expected in Q1 2017.

4. mcTMS treatment response rates were found to be markedly higher than that reported by single-coil TMS approaches for treatment-resistant depression.

5. Clinical studies (Stanford University) have shown that mcTMS can markedly reduce both acute and chronic pain.

6. Ongoing research at Stanford University has demonstrated proof of principle for a novel mcTMS pulsing method that can enhance plasticity (RGN-owned IP), a foundation for next generation TMS methodology that may be far more efficacious and require fewer treatments.

PEMF

1. PEMF is a portable CE/CSA-marked FDA-cleared treatment for postoperative pain and edema and in randomized controlled clinical studies has been found to be safe and able to significantly reduce pain, narcotic pain medication use, edema, and inflammatory cytokine production.

2. PEMF is currently in use clinically, is reimbursed by Medicare for treating chronic wounds, and can be further commercialized on-label in the US and abroad.

3. PEMF has no known or observed side effects nor any associated adverse events.

4. Preclinical studies have demonstrated that brief treatments with RGN’s PEMF significantly reduce neuroinflammation and promote neuroprotection and that PEMF is protective in animal models of brain injury, stroke, and multiple sclerosis.

5. PEMF operates via induction and therefore the blood brain barrier does not hinder delivery of the therapy to the brain parenchyma, which is a critical challenge for CNS drug development.

6. RGN is studying at-home PEMF treatment, delivered via the TheraCap™, in patients with post-concussion syndrome at Harvard’s Spaulding Rehabilitation Hospital and encouraging clinical pilot results indicate that treatment is resulting in reduced symptoms and enhanced cerebral blood flow.

7. RGN has IRB-approved clinical trials planned to investigate PEMF as (1) a treatment for acute concussion and (2) adjunctive treatment for symptoms associated with multiple sclerosis.

8. Clinical studies confirming PEMF anti-neuroinflammatory and/or neuroprotective effects pave a path toward other high impact indications related to neurodegenerative disease and psychiatric illness.

clTES

1. NeuroMod16 was built in response to the lack of a safe, effective, and reliable commercial device for multichannel electrical brain stimulation.

2. NeuroMod16 is currently integrated into a cl-TES system in which it responds to real time EEG signals and can be integrated into other closed loop systems.

3. The NeuroMod16 delivers cl-TES via RGN’s proprietary electrodes that substantially increase the safety and comfort of TES.

4. The NeuroMod16 and associated electrodes can deliver conventional (tDCS, tACS, tRNS) or non-conventional (user-specified) waveforms with high levels of precision in open or closed-loop systems that are responsive to neurological or physiological events.

5. Each of the 16 channels operates independently in terms of frequency, amplitude, latency, location, and duration of stimulation.

6. The NeuroMod16 is modular and multiple units can be connected to create high density, high spatial resolution cl-TES.

7. The NeuroMod16 is the only device available with these advanced capabilities.

8. RGN electrodes can be implemented in any montage to meet virtually any user need.

9. US Air Force exclusively uses RGN electrodes for brain stimulation.

10. The U.S. Department of Defense has expressed interest in deploying the Neuromod16 as part of a training enhancement protocol that incorporates virtual reality and EEG.

11. The NeuroMod16 is ready for commercialization and partnership with distributors is underway.

Impact of Technology on the Market

RGN’s development of the three NIBS technologies is rooted in the understanding that non-invasive approaches will often be sought before invasive technologies that require surgery and the associated risks. Further, aggregation of three different NIBS technologies and methods is informed by activity in the nascent field of neuromodulation, which is still unfolding which modalities will work best for different clinical conditions or performance goals. Therein, each of RGN’s devices offers a unique value proposition.

mcTMS

1. RGN owns the only multicoil TMS device and the multicoil approach has a number of advantages over single coil TMS devices.

2. Single coil devices exhibit either shallow and focused stimulation (small diameter coils) or deep and diffuse stimulation (large diameter coils), but cannot stimulate deeper brain structures with selectivity.

3. Multicoil TMS employs an array of coils that steer induced electrical currents so as to optimally modulate targeted brain regions not reachable by single-coil devices. This approach has been shown to be clinically effective in depression and results in higher treatment response rates than single-coil TMS devices.

4. FDA 510k clearance is expected in Q1 2017, after which commercialization can be pursued.

5. RGN’s IP position prevents competitors from using multiple coils.

6. New data suggest that a novel multicoil TMS pulsing sequence can enhance plasticity (RGN-owned IP), an approach that may result in a next generation TMS methodology that could dramatically increase efficacy and reduce treatment duration compared to current standards.

7. RGNs novel mcTMS business model is expected to capture significant market share and put pressure on single-coil competitors.

PEMF

1. RGN’s PEMF technology is a non-invasive radiofrequency device that has been shown to have potent anti-inflammatory effects and no side effects in blinded randomized controlled trials and anti-neuroinflammatory and neuroprotective effects in preclinical studies.

2. RGN has transitioned to studying PEMF treatment, via TheraCapTM, as an intervention for neuroinflammation associated with mild traumatic brain injury and multiple sclerosis.

3. Preliminary results from a post-concussion syndrome pilot trial indicate that PEMF promotes resolution of symptoms and mechanistic outcomes are planned.

4. Given continued positive results and regulatory approval, PEMF therapy would become the first labeled treatment for brain injury, a vast market and critical unmet need in neurological therapeutics.

5. Clinical evidence that PEMF reduces neuroinflammation non-invasively would create a clear path toward several other neurological and psychiatric indications with unmet treatment needs.

6. The attractive safety profile and non-invasive nature of PEMF will position it to compete with potential drug competitors with adverse effects and/or be used adjunctively.

clTES

1. RGN’s TES device, the NeuroMod16, was built in response to the lack of a safe, effective, and reliable commercial device for multichannel TES.

2. RGN’s clTES electrodes provide a safe, stable, and comfortable platform for delivering electrical NIBS.

3. The NeuroMod16 and associated electrodes can deliver conventional (tDCS, tACS, tRNS) or non-conventional (user-specified) waveforms in open or closed-loop systems that are responsive to neurological or physiological events.

4. Each of the 16 channels operates independently in terms of frequency, amplitude, latency, and duration of stimulation.

5. The NeuroMod16 is the only device available with these advanced capabilities.

6. RGN can have the NeuroMod16 manufactured at a cost that will allow it to be priced to disrupt the current TES stimulator market.

Intellectual Property Summary

RGN has an expansive portfolio of intellectual property that covers important methods and uses of NIBS. At present, RGN has (U.S.) 13 issued patents, 8 pending patents for mcTMS (some of which are licenses from Stanford University that are assignable), 13 issued patents, 14 pending patents for PEMF, and 2 pending patents for clTES. More detail can be found in Appendix C. The portfolio represents a broad array of strategic variables including:

mcTMS
1. Device for selective deep brain stimulation via multi-coil magnet arrays.
2. Methods for selectively modulating deep areas of the brain with shaped magnetic fields, using sulci as pathways for current flow.
3. Shaping of pulsed magnetic field is changed by altering the polarity of individual magnets with an array.
4. Use of different pulse rates from individual coils in one array and latencies between their discharges to achieve specific neuromodulation effects.
5. Network-based deep brain stimulation using multiple pulsed magnetic sources.

PEMF
1. RGN’s Neurological PEMF portfolio (5 issued and 3 pending) includes a broad set of applications of PEMF in neurological injury and trauma, neurological pain, neurodegenerative disease, stroke, multiple sclerosis, and prophylactic protection of neural tissue (neuroprotection).
2. RGN’s General PEMF portfolio (8 issued and 11 pending) provides broad protection on the configuration of PEMF devices and signals dating back to 1997, and includes integration of PEMF into clothing, wearables (e.g., TheraCap tm), and furniture.
3. RGN also has strong supporting IP for specific applications of PEMF outside of the CNS including wound repair, treatment of degenerative joint disease, cardiovascular disease, and angiogenesis.
4. RGN continues to actively pursue IP development, in part based on over a decade of research into PEMF signal transduction and mechanism(s) of action.
5. RGN has several PEMF patents providing international IP protection.

clTES
1. clTES has an intellectual property position (2 pending patents) that covers methods, devices, and electrodes that enhance the safety, comfort, effectiveness, flexibility, and ease of use of electrical neuromodulation over currently used methods.
2. Methods: The intellectual property position covers a methodology that looks at brain function first to determine the parameters for the delivery of clTES. Dubbed the REVS approach, our methods prescribe Recording brain activity, Evaluating the differences between optimal and dysfunctional brain states, Virtualizing the stimulation parameters to determine the optimal intervention in terms of frequency, amplitude, latency, location, and duration, and finally Stimulating the brain to effect the desired behavioral change.
3. Devices: The intellectual property specifies the parameters for the NeuroMod16 device that is unique among TES devices that are currently on the market. The NeuroMod16 has 16 independent channels that can be monopolar or bipolar in any combination, can deliver any user specified wave form, accepts external triggers for inclusion in clTES systems, has one touch operation for error reduction, and custom software for device control.
4. Electrodes: The intellectual property includes electrode assemblies that have proven safe and effective in multiple peer reviewed papers, have low sensation and side effect profiles, are stable over long periods, and have never caused a burn.

RGN’s Assets

RGN has developed a technology portfolio that spans three modalities of NIBS and has applications in neurological disease and trauma, psychiatric illness, and performance enhancement. These assets fall into a variety of categories, including:

1. Patents, patent applications, and trademarks

2. PEMF 510(k) clearance in post-surgical market, pending mcTMS 510(k) clearance for depression

3. Technology addressing the estimated the multibillion dollar global markets for treating depression, postoperative pain, brain injury, multiple sclerosis, and cognitive enhancement

4. Established and certified reimbursement codes

5. mcTMS clinical trial data for drug-resistant depression and pain

6. PEMF clinical trial data for post-surgical pain, opiate reduction, swelling, inflammation

7. PEMF pilot trial data for treating post-concussion syndrome

8. TES study data for cognitive enhancement

9. DoD research subcontract (through 2017) – Enhancing Learning & Memory with Brain Stimulation

10. Unique and clinically relevant patient data

11. IRB-approved study plans

12. Market supporting clinical trials underway

13. Next generation product designs

14. Product cost reduction designs

15. Manufacturing and design equipment

16. Device inventory for all three technologies

17. Intellectual capital and expertise

The assets of RGN will be sold in whole or in part (collectively, the “RGN Assets”). The sale of these assets is being conducted with the cooperation of RGN. RGN and its employees will be available to assist purchasers with due diligence and a prompt, efficient transition to new ownership. Notwithstanding the foregoing, RGN should not be contacted directly without the prior consent of Gerbsman Partners

Management
Steven Gluckstern, Ed.D., MBA – President & CEO

Steven has served as RGN’s president and CEO since 2011. Previously he has served as Chairman and CEO of Ivivi Health Sciences, Zurich Scudder Investments, and Centre Reinsurance.

Blake Gurfein, Ph.D. – Chief Science Officer
Blake is a neuroimmunologist and faculty member at the University of California San Francisco. Blake worked with RGN as a consultant from 2013-2014 and joined the company as Chief Science Officer in 2014. In this role, Blake oversees basic science and clinical research activities, manages staff, and interfaces with the medical advisory board. Blake has 15 years of experience in neuroscience and immunology research and has been involved in the design, development, and preclinical/clinical investigation of medical devices.

Sean Hagberg, Ph.D. – Chief Strategist
Sean co-founded RGN in 2011 and in 2004 co-founded Ivivi Technologies, which developed RGN’s PEMF technology. Sean is a faculty member at the University of New Mexico and served as Chief Science Officer of Ivivi and led the scientific and clinical research program, including several first-in-human RCTs with using PEMF. Sean has been involved in all aspects of PEMF IP development, testing, basic science through clinical trials and regulatory processes.

Michael Weisend, Ph.D. – Senior Scientist
Mike is a neuroscientist and faculty member at the University of New Mexico, Wright State University, and The Mind Research Network. Mike consulted for RGN from 2011 to 2015 and joined as a senior scientist in late 2015. Mike has 25 years of experience in neuroimaging, brain stimulation, and device development with emphases in memory, epilepsy, mental illness.

Peter Schwartz, Ph.D. – Director of Engineering
Peter is an engineering executive with a background rooted in science, and he has worked with RGN since 2015, spearheading the mcTMS 510(k) effort. Peter has 20 years of experience in research and development of capital equipment ushering inventions from the laboratory through commercialization.

Bret Schneider, M.D. – Senior Scientist

Bret is the principal inventor of multi-coil TMS and has 25 years of experience in neurotechnology development. Bret is also a Consulting Associate Professor of Psychiatry at Stanford University School of Medicine and a practicing psychiatrist.

Board of Directors

Steven Gluckstern, Chairman: CEO, Rio Grande Neurosciences
Stephen Juelsgaard, D.V.M., J.D.: Former General Counsel, Genentech
John Wilkerson: Managing Director, Galen Partners

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a Confidential Disclosure Agreement (attached hereto as Appendix B) to have access to key members of management and intellectual capital teams and the due diligence “war room” documentation (“Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has had an opportunity to inspect and examine the RGN Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and Gerbsman Partners (and their respective staff, agents, or attorneys) do not make any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the RGN Assets. Each sealed bid must be submitted so that it is received by Gerbsman Partners no later than Monday, January 24, 2017 at 3:00pm Pacific Standard Time (the “Bid Deadline”) at 211 Laurel Grove Avenue, Kentfield, CA 94904. Please also email steve@gerbsmanpartners.com with any bid.

Bids should identify those assets being tendered for in an identifiable way. Specifically, RGN’s three core assets, multicoil transcranial magnetic stimulation, pulsed electromagnetic field technology, and closed-loop transcranial electrical stimulation platform, can be bid on in whole or in part.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase. All bids must be accompanied by a refundable deposit in the amount of $200,000 (payable Rio Grande Neurosciences, Inc.). The deposit should be wired to RGN’s attorneys Mitchell Silberberg & Knupp. The winning bidder will be notified within 3 business days of the Bid Deadline. The deposit will be held in trust by RGN’s counsel. Unsuccessful bidders will have their deposit returned to them within 3 business days of notification that they are an unsuccessful bidder.

RGN reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest and best bid submitted will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.

RGN will require the successful bidder to close within a 7 day period. Any or all of the assets of RGN will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the RGN Assets shall be the sole responsibility of the successful bidder and shall be paid to RGN at the closing of each transaction.

For additional information, please see below and/or contact:

Steven R. Gerbsman
Gerbsman Partners
(415) 456-0628
steve@gerbsmanpartners.com

Kenneth Hardesty
Gerbsman Partners
(408) 591-7528
ken@gerbsmanpartners.com

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Oct 25, 2016 Update to InterValve, Inc. BAV and the Second Tsunami in AS patients

Posted in Uncategorized, tagged , , , , , , on October 24, 2016| Leave a Comment »

Good morning.

In considering the “Date Certain M&A” of InterValve, Inc., I have attached a presentation from InterValve “Does BAV (“Bicuspid Aortic Valvuloplasty”) Work.

Also, in the Oct 11th, 2016 issue of JACC (“Journal of the American College of Cardiology”), Dr. John Carroll from the University of Colorado published an editorial on a recent TAVR study which I think will be of interest to potential bidders.

Click on this link for the editorial: https://content.onlinejacc.org/article.aspx?articleID=2557468

What is of interest is the excellent job Dr Carroll does in framing the issues anticipated by the surging number, literally millions, of symptomatic calcified aortic stenosis (AS) patients in the near future. Driven by the aging population, Dr Carroll terms the trend a “second tsunami” of AS patients which challenges the current treatment options.

Balloon aortic valvuloplasty (BAV) could/should/will play a role in managing these patients particularly given the V8 technology. Up to now, BAV has been poorly utilized. With the significant change in aortic valve area that the V8 provides over conventional balloons, physicians could revisit the role of BAV in managing these patients.

Mark Ungs, CEO of InterValve, Inc. is available, along with the Gerbsman Partners team to discuss in greater detail and set up due diligence, if appropriate.

Also, please see below information on “The Bidding Process, Procedures for the Sale of certain Assets and Intellectual Property of InterValve, Inc.

Best regards

Steve Gerbsman

The Bidding Process, Procedures for the Sale of certain Assets and Intellectual Property of InterValve, Inc.

Further to Gerbsman Partners Update on October 16, 2016 regarding the sale of certain assets of InterValve, Inc. (“InterValve”), I am attaching the Asset Purchase Agreement (“APA”) that is required with any bid and refundable wire transfer information for interested parties bidding on the assets and IP of InterValve.

Ken, Dennis and I will be following up to review the Bidding Process, schedule due diligence meetings and answer any questions regarding the “Date Certain M&A Process”.

Gerbsman Partners (http://www.gerbsmanpartners.com) has been retained by InterValve, Inc. (http://intervalveinc.com) to solicit interest for the acquisition of all or substantially all of InterValves’s assets, including its Intellectual Property (“IP”), in whole or in part (collectively, the “InterValve Assets”).

Any and all the assets of InterValve will be sold on an “as is, where is” basis and will be subject to “The Bidding Process for Interested Buyers”, outlined below.

Prior to the bid date of November 16, 2016, I would encourage all interested parties to have their counsel speak with William Kaufman, Esq. of Fox Rothschild LLP – wkaufman@foxrothchilds.com at 612 617–7485 regarding reviewing and negotiating the attached “APA”. He is available to discuss any questions or comments of a legal nature relating to the transactions contemplated by the “APA”.

IMPORTANT LEGAL NOTICE

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to InterValve’s Assets has been supplied by InterValve. It has not been independently investigated or verified by Gerbsman Partners or their respective agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.

Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of InterValve’s or Gerbsman Partners’ negligence or otherwise.

Any sale of the InterValve Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of InterValve and Gerbsman Partners. Without limiting the generality of the foregoing, InterValve and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the InterValve Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the non-disclosure agreement attached hereto as Exhibit A.

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a nondisclosure agreement (attached hereto as Exhibit A) to have access to key members of the management and intellectual capital teams and the due diligence “war room” documentation (the “Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has an opportunity to inspect and examine the InterValve Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of InterValve, Inc., Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and neither InterValve nor Gerbsman Partners (or their respective, staff, agents, or attorneys) makes any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the InterValve Assets. Sealed bids must be submitted so that the bid is actually received by Gerbsman Partners no later than November 16, 2016 at 3:00 p.m. Central Standard Time (the “Bid Deadline”) at InterValve’s office, located at 2445 Xenium Lane North, Plymouth, Minnesota 55441. Please also email steve@gerbsmanpartners.com with any bid.

Bids should identify those assets being tendered for in a specific and identifiable way. The attached InterValve fixed asset list may not be complete and Bidders interested in the InterValve’s Assets must submit a separate bid for such assets. Be specific as to the assets desired.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase where applicable. All bids must be accompanied by a refundable deposit check in the amount of $200,000 (payable to InterValve, Inc.). The winning bidder will be notified within 3 business days after the Bid Deadline. Non-successful bidders will have their deposit returned to them.

InterValve reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest bid will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.

InterValve will require the successful bidder to close within 7 business days. Any or all of the assets of InterValve will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the InterValve Assets shall be the sole responsibility of the successful bidder and shall be paid to InterValve at the closing of each transaction.

For additional information, please see below and/or contact:

Steven R. Gerbsman
steve@gerbsmanpartners.com

Kenneth Hardesty
ken@gerbsmanpartners.com

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October 24, 2016 Update to the Bidding Process for “Date Certain M&A”of InterValve, Inc.- its Assets and Intellectual Property – Gerbsman Partners

Posted in Uncategorized, tagged , , , , , on October 21, 2016| Leave a Comment »

The Bidding Process, Procedures for the Sale of certain Assets and Intellectual Property of InterValve, Inc.

Further to Gerbsman Partners Update on October 16, 2016 regarding the sale of certain assets of InterValve, Inc. (“InterValve”), I am attaching the Asset Purchase Agreement (“APA”) that is required with any bid and refundable wire transfer information for interested parties bidding on the assets and IP of InterValve.

Ken, Dennis and I will be following up to review the Bidding Process, schedule due diligence meetings and answer any questions regarding the “Date Certain M&A Process”.

Gerbsman Partners has been retained by InterValve, Inc. to solicit interest for the acquisition of all or substantially all of InterValves’s assets, including its Intellectual Property (“IP”), in whole or in part (collectively, the “InterValve Assets”).

Any and all the assets of InterValve will be sold on an “as is, where is” basis and will be subject to “The Bidding Process for Interested Buyers”, outlined below.

Prior to the bid date of November 16, 2016, I would encourage all interested parties to have their counsel speak with William Kaufman, Esq. of Fox Rothschild LLP – wkaufman@foxrothchilds.com at 612 617–7485 regarding reviewing and negotiating the attached “APA”. He is available to discuss any questions or comments of a legal nature relating to the transactions contemplated by the “APA”.

IMPORTANT LEGAL NOTICE

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to InterValve’s Assets has been supplied by InterValve. It has not been independently investigated or verified by Gerbsman Partners or their respective agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.

Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of InterValve’s or Gerbsman Partners’ negligence or otherwise.

Any sale of the InterValve Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of InterValve and Gerbsman Partners. Without limiting the generality of the foregoing, InterValve and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the InterValve Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the non-disclosure agreement attached hereto as Exhibit A.

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a nondisclosure agreement (attached hereto as Exhibit A) to have access to key members of the management and intellectual capital teams and the due diligence “war room” documentation (the “Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has an opportunity to inspect and examine the InterValve Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of InterValve, Inc., Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and neither InterValve nor Gerbsman Partners (or their respective, staff, agents, or attorneys) makes any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the InterValve Assets. Sealed bids must be submitted so that the bid is actually received by Gerbsman Partners no later than November 16, 2016 at 3:00 p.m. Central Standard Time (the “Bid Deadline”) at InterValve’s office, located at 2445 Xenium Lane North, Plymouth, Minnesota 55441. Please also email steve@gerbsmanpartners.com with any bid.

Bids should identify those assets being tendered for in a specific and identifiable way. The attached InterValve fixed asset list may not be complete and Bidders interested in the InterValve’s Assets must submit a separate bid for such assets. Be specific as to the assets desired.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase where applicable. All bids must be accompanied by a refundable deposit check in the amount of $200,000 (payable to InterValve, Inc.). The winning bidder will be notified within 3 business days after the Bid Deadline. Non-successful bidders will have their deposit returned to them.

InterValve reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest bid will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.

InterValve will require the successful bidder to close within 7 business days. Any or all of the assets of InterValve will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the InterValve Assets shall be the sole responsibility of the successful bidder and shall be paid to InterValve at the closing of each transaction.

For additional information, please see below and/or contact:

Steven R. Gerbsman
(415) 456-0628
steve@gerbsmanpartners.com

Kenneth Hardesty
(408) 591-7528
ken@gerbsmanpartners.com

Read Full Post »

October, 2016 “Date Certain M&A” – InterValve, Inc.- Gerbsman Partners

Posted in Uncategorized, tagged , , , , , , on October 12, 2016| Leave a Comment »

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SALE OF INTERVALVE, INC.

Gerbsman Partners has been retained by InterValve, Inc.  to solicit interest for the acquisition of all, or substantially all, the assets of InterValve, Inc.

InterValve is a privately held medical decive company located in Plymouth, Minnesota, founded in January 2004. InterValve was created to develop support devices for the multibillion dollar Structural Heart market. The acquisition of InterValve enables immediate participation or expansion in this large and growing market. InterValve has raised one round (and one extension) of private financing to date totaling $12 million from private individuals and one strategic partner. The company has also received financing in the form of a $3 million loan from Oxford Finance LLC, the senior secured lender.

InterValve has developed and commercialized a proprietary aortic valvuloplasty balloon (the V8TM) that improves clinical outcomes and appears safer than conventional options. InterValve has also prototyped or patented enhancements to this balloon platform that extends its design to other Structural Heart valve applications. InterValve has nine issued patents, three “Notice of Allowance”, four pending patent applications, and five trademarks.

Based on solid clinical data and design advantages, the V8 is sold in over fifty US hospitals with established repeat sales, and several European countries. It recently received regulatory clearance in Canada, Russia, New Zealand and Argentina. The company is prepared to launch its fifth generation product which has received favorable responses in beta-site evaluations.

InterValve had revenues of approximately $410k through the first six months of 2016, a 254% increase over the prior six months. Production and sales were suspended in July, 2016 due to a manufacturing issue, which since has been resolved. Although there was enthusiasm for the launch of the fifth generation product, with the launch delay the Board of Directors did not see a direct path for additional needed equity investment but instead made a decision to maximize and monetize the value of InterValve’s Intellectual Property and proven commercial success.

IMPORTANT LEGAL NOTICE:

The information in this memorandum does not constitute the whole or any part of an offer or a contract.

The information contained in this memorandum relating to InterValve’s Assets has been supplied by InterValve. It has not been independently investigated or verified by Gerbsman Partners or its agents.

Potential purchasers should not rely on any information contained in this memorandum or provided by InterValve, or Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.

InterValve, Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of InterValve’s or Gerbsman Partners’ negligence or otherwise.

Any sale of the InterValve Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of InterValve or Gerbsman Partners. Without limiting the generality of the foregoing, InterValve and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the InterValve Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the non-disclosure agreement attached hereto as Exhibit A.

Historical Company Information

InterValve developed, patented, and commercialized an aortic valvuloplasty catheter based on a critical change in shape of the dilatation balloon. Conventional valvuloplasty catheters use a cylindrical-shaped balloon, however, since the aortic valve anatomy is non-cylindrical, these traditional devices are limited in effectiveness and safety. InterValve’s V8TM catheter utilizes an anatomically-shaped dilatation balloon which enhances clinical effectiveness, improves ease-of-use, and appears to reduce clinical risks. In a published study of stand-alone valvuloplasty procedural outcomes, the V8 showed a change in valve area 76% higher than a matched cohort using conventional cylindrical-shaped balloons. In a separate publication, when the V8 was used to post-dilate a self-expanding transcatheter aortic valve replacement (TAVR) prosthesis, the V8 showed a higher than historic success in resolving paravalvular leak (PVL) without an increase in adverse events. Finally, when used to predilate the native aortic valve prior to a TAVR procedure, the V8 can be used without rapid ventricular pacing (RVP) which, by its elimination, benefits patients with compromised hemodynamic function.

InterValve believes the V8 provides a sustainable and growing commercial asset in the structural heart market for the following reasons:

1. Public clinical data suggests that the proprietary anatomically-shaped dilatation balloon confers a demonstrable clinical and procedural advantage over conventional cylindrical-shaped balloons.

2. The V8 is the only commercially available valvuloplasty catheter that is cleared for post dilatation of self-expanding TAVR devices, and the optional use of RVP during inflation.

3. 254% increase in revenue in the first six months of 2016 compared to the previous six months. Over 50 US accounts with repeat sales.

4. Competitive manufacturing costs with higher than average sales price provide attractive margins.

5. Well established reimbursement codes exist for stand-alone valvuloplasty procedures.

6. Manufactured by a 3rd-party that supplies large med-tech strategics that can ramp up latest generation product to launch quantities in four months.

7. The V8 has been favorably used clinically to treat the pulmonic valve, and its anatomical shape could be adopted for mitral valve applications with similarly expected clinical advantages.

8. Nine issued patents, three Notice of Allowance received, four pending applications.

9. The potential to expand the technology by patented valvuloplasty enhancements including: perfusion to extend inflation dwell times for local drug or ultrasound energy delivery; patented and prototyped radiopaque surface rings which enable intraprocedural valve annulus measurements using conventional on-screen fluoroscopy equipment; patented enhanced procedure safety through inflation pressure spill off to prevent excessive dilatation pressures.

10. The potential for significantly expanding the BAV market by re-educating the medical community on the true effectiveness of aortic valvuloplasty to dramatically improve NYHA class in severe symptomatic AS patients, and the potential to improve life expectancy in these same patients.

InterValve Company Profile

InterValve was founded by a highly experienced group of cardiologists and industry executives to develop and commercialize a novel, purpose-built aortic valvuloplasty balloon to improve TAVR and balloon aortic valvuloplasty (BAV) procedures. The InterValve V8TM is the first, and only, commercialized valvuloplasty balloon that is anatomically shaped throughout inflation.

The V8 catheter is used in three procedures:

1) Stand-alone BAV
2) Predilatation of the native aortic valve prior to TAVR device implantation
3) Self-expanding TAVR device post-dilation to resolve persistent PVL

Since its commercial introduction in 2014, over 3,000 clinical cases, three publications, and two registries have shown the V8 delivers superior outcomes in all three applications:

1. With stand-alone BAV procedures, published change in AVA was 76% greater than a comparative group of patients treated with conventional catheters.

2. The V8 provides a benefit to TAVR patients with poor hear function because of its ability during predilate without rapid ventricular pacing.

3. In two registries the V8, when used to post-dilate, provided a near total resolution of residual PVL with self-expanding TAVR devices compared to reported 45% – 75% success using conventional balloons.

InterValve has created an extensive patent portfolio consisting of nine issued US patents, three Notice of Allowance, and four applications pending.

Impact of Technology on the Market

The V8 product has the potential to fundamentally reshape the three markets it competes in, and when viewed as a platform technology, to expand beyond the aortic valve market.

BAV Market:
The V8 could be the market leader in the BAV marketplace based on its early success. As mentioned earlier, the catheter’s anatomical shape confers greater procedural efficacy without increasing adverse events.

The V8 also has the potential to dramatically grow the BAV market. Historically, BAV has been limited to palliative procedures that “doesn’t work”, and limited to palliative procedures, however, this is not an accurate characterization. In the early 90’s when BAV was first evaluated in several large clinical trials, the results showed that BAV provides dramatic symptomatic relief for severe symptomatic AS. However restenosis at 12 to 18 months, and more importantly, a 3% procedural mortality rate, limited its use to relief of symptoms. Therefore, to be more precise, BAV does work, but its duration is limited.

However, InterValve believes BAV and more specifically the V8 technology has a bright future.

1. Interventional procedural techniques have improved since the 90’s reducing the BAV procedure mortality rate to less than 1%. The evidence to date suggests the V8’s shape reduces this risk even further.

2. If BAV was shown to increase life expectancy, the view of the procedure would fundamentally change. Retrospective review of BAV trial results indicate that BAV can reduce mortality if a certain threshold aortic valve area (AVA) is reached (ie: patients with an AVA >/= 1 cm2 live longer than when AVA < 1 cm2). Given that the V8 consistently provides a final AVA value higher than cylindrical balloons, the V8 may be the ideal technology to demonstrate that BAV can reliably extend lifespan, therefore, expanding its usage.

3. BAV procedures could play more of a complementary role relative to TAVR in treating high risk AS patients. As reported in PARTNER Cohort B, there was no mortality difference during the first six months post procedure among high risk surgical patients that were treated with TAVR versus BAV (using cylindrical balloons). If the V8 were to show a positive impact to mortality, more physicians would consider using BAV in lieu of TAVR for patients with limited life expectancy (ie: < 1 year) estimated at about a third of high risk patients. In addition, the high cost of TAVR procedures, about eight times that of a BAV procedure, would put BAV in a more favorable light in today’s health care market. Eliminating rapid ventricular pacing further differentiates the V8 as the best TAVR predilation balloon on the market.

4. The V8’s shape “self seeks” the aortic annulus making it an ideal balloon platform for precise delivery of drugs or energy to augment emerging valve therapies. The anatomical shape also safely maximizes balloon to anatomy contact which could be critical to the success of an emerging new therapy. Lastly, addition of perfusion to extend inflation times, shorter procedure times and reduced patient risk.

TAVR predilatation
The next generation V8 device has a working length of just 2.4cm compared to 4cm typical for today’s balloon options. This length reduction is possible because the V8 shape locks into the aortic valve anatomy preventing balloon migration, or slippage, during inflation. The shorter length is favored by users because it results in less inflation volume, hence, faster inflation/deflation times. Since rapid ventricular pacing is optional with the V8, it clearly stands out as the best predilatation balloon on the market.

In addition, the most recent data is demonstrating that predilatation reduces cerebral ischemia. If this data continues to build, the market would embrace universal predilatation for TAVR, which the V8 would be well positioned to flourish commercially.

Post-dilation of TAVR devices
The anatomically shaped V8 is an ideal post-dilation balloon for self-expanding TAVR devices. While the rate of persistent PVL is dropping with advances in TAVR technology, physician tolerance for persistent PVL is approaching zero. Persistnet PVL shortens the life of the patient by as much as half of those patients without PVL. As TAVR technology is used increasingly in younger, healthier patients, PVL becomes unacceptable which is favorable for the V8.

InterValve’s Assets

From InterValve’s start, the emphasis has been to operate the company with as little overhead as possible by outsourcing all major activities. Some call this a “virtual” model. The company’s assets are contained in the following:

1. Patents, Patent Applications and Trademark

2. Significant intellectual capital, know-how and expertise in the device treatment of aortic stenosis

3. Experience from over 3,000 commercial uses of the V8

4. Clinical data from three registries, two manuscripts, and two abstracts

5. Fixed assets of approximately $100,000 including a 500 square foot portable clean room.

The assets of InterValve will be sold in whole or in part (collectively, the “InterValve Assets”). The sale of these assets is being conducted with the cooperation of InterValve. InterValve and its consultants will be available to assist purchasers with due diligence and a prompt, efficient transition to new ownership.

The V8 product is manufactured by Vention Medical in Brooklyn Park, Minnesota. Vention Medical is an established, qualified manufacturer in the medical device industry that supplies product to major med-tech strategics. Launch quantities of our latest generation product can be made in four months.

InterValve’s new owner can elect to continue using Vention Medical as the manufacturer of the V8 or chose to integrate the process. Per our agreement, Vention will transfer the manufacturing process as directed to another party, charging a predetermined hourly rate for their employee time spent. The exception to a complete transfer is the balloon component which is the property of Vention Medical, though they will supply this component to the receiving party.

InterValve, Inc. Key Personnel
Mark T. Ungs — President and CEO/Board Member: Mark Ungs has led the company’s product development, product planning, operations, and relationships since 2008. Prior to InterValve, he served as the Vice President of New Business Development for Boston Scientific’s multi-billion dollar Interventional Cardiology division where he was responsible for leading the division’s growth outside its core businesses through internal development programs as well as external technology acquisitions into new therapies. He has thirty years professional experience in the medical device industry. He has a degree in Chemical Engineering from Oregon State University and an MBA from the University of California, Berkeley.

William J. Drasler — Chief Technology Officer: William Drasler has over 30 years professional experience in the medical device field. Prior to InterValve, he held the position of VP of Applied Research at Boston Scientific where he directed leading edge development of cardiovascular devices and treatments for CHF, AMI, Stroke, and other clinically relevant problems. His experience includes VP of R&D for Possis Medical where he took the Angiojet thrombectomy project from inception through to production, VP of Engineering at Lake Region Manufacturing which manufactures guidewires and filters, and SciMed Life Systems where he worked on balloon bonding and balloon technology. Dr. Drasler has over 30 major US patents and holds a MS in Chemical Engineering from UW Madison and a PhD in Biomedical Engineering from the University of Minnesota with research experience in fluid mechanics, blood rheology, and Sickle Cell disease.

InterValve, Inc. Board of Directors
Michael Berman: Investor/entrepreneur
Robert Van Tassel, MD: Retired cardiologist, Minneapolis Heart Institute

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a nondisclosure agreement (attached hereto as Exhibit A) to have access to key members of the management and intellectual capital teams and the due diligence “war room” documentation (the “Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has an opportunity to inspect and examine the InterValve Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of InterValve, Inc., Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and neither InterValve nor Gerbsman Partners (or their respective, staff, agents, or attorneys) makes any representations as to the accuracy or completeness of the same.

Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the InterValve Assets. Sealed bids must be submitted so that the bid is actually received by Gerbsman Partners no later than November 16, 2016 at 3:00 p.m. Central Standard Time (the “Bid Deadline”) at InterValve’s office, located at 2445 Xenium Lane North, Plymouth, Minnesota 55441. Please also email steve@gerbsmanpartners.com with any bid.

Bids should identify those assets being tendered for in a specific and identifiable way. The attached InterValve fixed asset list may not be complete and Bidders interested in the InterValve’s Assets must submit a separate bid for such assets. Be specific as to the assets desired.

Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase where applicable. All bids must be accompanied by a refundable deposit check in the amount of $200,000 (payable to InterValve, Inc.). The winning bidder will be notified within 3 business days after the Bid Deadline. Non-successful bidders will have their deposit returned to them.

InterValve reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest bid will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.

InterValve will require the successful bidder to close within 7 business days. Any or all of the assets of InterValve will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the InterValve Assets shall be the sole responsibility of the successful bidder and shall be paid to InterValve at the closing of each transaction.

For additional information, please see below and/or contact:

Steven R. Gerbsman
(415) 456-0628
steve@gerbsmanpartners.com

Kenneth Hardesty
(408) 591-7528
ken@gerbsmanpartners.com

Read Full Post »

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