SALE 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.
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.
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.
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 email@example.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