Feeds:
Posts
Comments

Good afternoon

Please see below.  Ken Hardesty, CEO in Residence at Gerbsman Partners, with the CEO of the Dubai Stock Exchange and Steve Wozniak.

Gerbsman Partners has the capability to access key resources for capital and strategic relationships in Dubai and the UAE and other regions around the world.

For additional information Steve and Ken are available to strategize and develop action plans for maximizing and monetizing value.

Best

Steve

Serene Medical has made a strategic decision to revisit the “SALE OF the assets of Serene Medical Pty Ltd”.  In consideration for acquiring the Serene IP and assets, Serene will be paid a negotiated royalty based on revenue, once the IP is commercialized.  Please see below and attached information on Serene and its IP and assets.  

Subject to the “Bidding Process” below, interested parties will be expected to bid on the IP and assets of Serene and negotiate a back end royalty on or before December 30, 2021.

The Gerbsman Partners team is available to discuss and set up calls with the key Intellectual Capital of Serene. 

Thank you for your time and consideration in reviewing this latest update regarding the assets and IP of Serene Medical.

Best regards

Steve Gerbsman 

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

Steven R. Gerbsman                                                                             

steve@gerbsmanpartners.com                          

Kenneth Hardesty

ken@gerbsmanpartners.com

SALE OF the assets of Serene Medical Pty Ltd

Gerbsman Partners (www.gerbsmanpartners.com) has been retained by Serene Medical Pty Ltd (www.serenemedical.com) to solicit interest for the acquisition of all, or substantially all, the assets of Serene Medical and its subsidiaries, further referred to as “Serene”, “Serene Medical” or “The Company”.  Please see attached Exhibit A, NDA, Exhibit B, IP Portfolio, Exhibit C, Inventory and detail Sales Letter with Appendix.

Based in Brisbane, Australia, Serene is a radio frequency (RF) medical device/technology company that employs its patented platform transdermal delivery technology. The offering consists of Nuebelle Therapy for aesthetic surgeons and for migraine specialists. 

Serene has raised approximately $35 million to date, with an initial $5 million focused on the clinical trials of the RF Technology. The majority shareholders are venture capital firms M.H. Carnegie & Co and January Capital. 

The Serene assets include IP/patents (16 registered patents), clinical trial results, inventory and fixed assets.

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

  • Serene’s patented technology has been demonstrated in an IRB, multi-site clinical trial to improve the appearance of glabellar lines for greater than six months.  This is a significantly longer duration than BOTOX®.
  • The patented technology has application in the aesthetics and migraine markets.  
  • 16 registered patents and one pending (see attached for details). 
  • The Company has inventory of approximately 100 RF Generators, 1000+ probes (outside date for clinical use) and some manufacturing equipment that is used for packaging the sterile probes. 
  • Serene’s technology offers a toxin free alternative for the long-term reduction of glabellar lines.
  • Large (>$2B) and growing (~5% annual rate) market. 
  • Physician revenue is >$4B (worldwide) for both aesthetics and migraine marketplaces, largely defined by BOTOX® (leading neurotoxin brand); >10M existing patients worldwide; ~10M more considering the treatment.
  • The aesthetics market has no reimbursement risk as it is a user pays market.
  • Clear regulatory path, clinical trial followed by FDA De Novo application. 
  • Both the aesthetics and migraine markets target a large patient pool, comprising a significant portion of consumers looking for a toxin free alternative to BOTOX®.

Serene History

The Serene technology has had approximately $35 million invested to date, with an initial $5 million focused on the clinical trials of the RF Technology. The majority shareholders are venture capital firms M.H. Carnegie & Co and January Capital. 

Founded in 2006 as Advanced Cosmetic Intervention Inc. (ACI), all funds and operations were targeted at developing a unique treatment for glabellar lines. In 2008 Advanced Headache Intervention Inc. (AHI), was formed to exploit the technology in the treatment of migraine. 

BioForm Inc. (BioForm) acquired ACI in late 2008 and furthered the development of the technology. More than $25 million was spent on the development and manufacturing of the technology. BioForm received FDA registration for the technology. BioForm was subsequently acquired by Merz Pharma (Merz) leaving the ACI technology orphaned. Serene was formed in 2010 and acquired the assets from Merz and AHI to commercialize the migraine and aesthetics technology.

Serene went on to raise over $10 million to conduct clinical trials and initiate commercial sales in the USA. An initial clinical trial of 78 patients was completed and formed the basis of an FDA De Novo application. This application was unsuccessful as the FDA required additional data. The venture capitalist investors are not in a position to continue to fund the commercialization of the Serene portfolio. 

Serene has also expanded the use of the technology for the prevention and management of migraine. Preparation for clinical research into this application was planned for early 2020, however did not go ahead due to funding challenges. Work needs to be done to determine the effectiveness and the most lucrative go-to-market channel and strategy.

Over the past three years Serene has worked to protect the Intellectual Property around the use of the technology in the aesthetic and migraine applications.

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 the Serene assets has been supplied by Serene.  It has not been independently investigated or verified by Gerbsman Partners, its agents or any other adviser.

Potential purchasers should not rely on any information contained in this memorandum or provided by Serene, 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.

Serene, 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 any loss arising from the provision of, or any omission from, such information, including that contained in this memorandum, whether that loss arises by reason of Serene Medical’s or Gerbsman Partners’ negligence or otherwise. 

Any sale of the Serene 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 Serene Medical, Gerbsman Partners or any other adviser.  Without limiting the generality of the foregoing, Serene Medical and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the Serene Medical assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, or any implied warranties of habitability, merchantability, or fitness for a particular purpose.

This memorandum contains confidential information and is not to be made available 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.

Serene Medical History and Background

Aesthetic treatments using BOTOX® or other similar toxins have become increasingly popular around the world. There have been segments of the market not comfortable with injecting toxins and also looking for a solution that would have a longer lasting effect than the typical three months delivered by BOTOX®. A market need for an alternate non-toxic treatment was identified and created with the Serene Nuebelle RF technology. 

The Serene RF System was originally developed by Advanced Cosmetic Intervention, Inc. (ACI) and cleared for marketing in the United States, under FDA 510(k) number K063753, as the GFX Nerve Ablation System. BioForm subsequently acquired the GFX Nerve Ablation System from ACI and a second FDA 510(k) submission was filed and cleared for software changes under K081729. Merz Pharma GmbH & Co later acquired BioForm and in 2011, Serene acquired the GFX Nerve Ablation System from Merz.

Clinical trials were conducted in 2015 that showed an effective reduction in the appearance of glabellar lines with the benefit lasting longer than 6 months on average. Serene submitted a De Novo application with the FDA for the registration of this clinical claim however it was rejected as the FDA required additional data to be included.

The clinical trial of 78 patients across 5 sites had excellent safety and efficacy data as shown below.

At this stage Serene has insufficient funds to restart the clinical trial, however the clinical plan is in place and additional clinical trials were planned to pursue the treatment of chronic migraine. A clinical trial was planned to investigate the impact of RF nerve ablation on chronic migraine starting in early 2020. 

Impact of Bi-polar RF Technology 

Bi-polar RF, the patented technology underlying all Serene products, is a very precise method of delivering uniform energy to a specific location. Combined with electrodes to stimulate the nerve the Serene dual-purpose Bi-polar RF probe is able to be accurately positioned near the target nerve to deliver a precise amount of energy that creates a lesion about the size of a grain of rice. This lesion results in a durable, toxin-free, long-term deactivation of target muscles.  

Bi-polar RF Nerve Ablation offers the following benefits compared to BOTOX®

  • Toxin free.
  • Longer duration. 
  • Procedure performed by clinicians.
  • Free from adverse effects associated with BOTOX® such as eyelid ptosis, brow ptosis, nausea, tiredness, double vision, decreased eyesight, and allergic reaction.(1).
1. From Botox IFU and data from FDA submission

                Pre-treatment ——-                                     3 Months Post Serene treatment

Intellectual Property 

Serene’s technology is protected by multiple issued patents in the United States and under The Patent Cooperation Treaty (PCT) internationally.

To date Serene has 16 registered patents and one patent application is in progress, as set out in Exhibit B.

Product Offerings

Serene has developed a radio frequency (RF) technology platform that was cleared (FDA 510(k)) for locating motor nerves and creating a thermal lesion to inhibit nerve conduction. The Company’s products include a control unit with full temperature feedback and a dual-purpose disposable probe.  

  • Bi-polar RF Probe (dual purpose).  The Company’s Bi-polar RF Probe has been designed to provide results that are more cumulative than immediate, administered by physicians with duration of effect lasting in excess of 6 months.  The Company has begun building the market for these products initially in the US, targeting the country’s aesthetic medical practices. The Company believes that early penetration of this market will allow it to validate its offering with highest threshold of clinical scrutiny, supported by assessments in peer-reviewed medical journals, which have already commenced.
  • Migraine Treatment.  The Company has identified a significant opportunity in the chronic migraine market. A phase one study has been prepared to demonstrate the efficacy of the technology in the long-term prophylactic treatment of chronic migraine.

PRODUCT DIFFERENTIATION

Professional: The Company’s Bi-polar RF Nerve Ablation Procedure is a premium procedure delivered by surgeons. Represented in the USA by ~7,000 Plastic Surgeons, ~2,000 Facial Plastic Surgeons, ~1,200 Oculoplastic Surgeons and ~2,000 Dermatologic Surgeons. 

Durability: Patients can benefit from the longer lasting effects of RF Nerve Ablation compared to the typically short (30-40 days) effective duration of BOTOX®

Toxin-free: A survey relating to the willingness of women to undertake toxin injections showed 36% of women were concerned with the safety of neurotoxins and 18% of women were concerned with looking natural after the treatment. 

Manufacturing

The products have all been manufactured by third party contract manufacturers in the USA. Full design documentation for the control unit and the Bi-polar RF probes will be available as part of the sale. 

Regulatory 

The Serene RF System design is identical to the system as cleared under FDA 510(k) numbers K063753 and K081729. The Serene RF System is composed of an RF Generator and a sterile, single-use RF Probe. The Serene RF System provides a minimally invasive technique for creating a neural lesion. The Generator and Probe are used as a system to both stimulate the nerve for the purpose of properly locating the probe and to create radiofrequency heat lesion in nerve tissue to inhibit or reduce nerve function. Stimulation energy is delivered, for example, to locate the nerve fibre that innervates a target muscle. During stimulation, the operator observes muscle movement. When the target muscle is stimulated, at the lowest possible current as assessed by the operator, the Probe is in the proper treatment location.

When the nerve is located and the probe is properly positioned, RF energy is delivered for the purpose of forming a lesion along the target nerve fiber. The thermal lesion induces a physiological response that inhibits conduction through the nerve, thereby decreasing muscle activity, which, for the proposed indication, results in the reduction of the appearance of dynamic wrinkles.

Clinical Trials – Subject to NDA and in Serene data room

In 2014/2015, the Company conducted a five-site, IRB approved clinical trial with Key Opinion Leader clinicians. The trial examined 78 patients healing after RF treatments and the reduction of the appearance of glabellar lines and wrinkles with a one-time application.  Both provider and patient assessments were very positive and validated what the Company was seeing in their proof-of-concept testing.:

——————————————————————————————

Management Team and Advisors

Board of Directors:

Trevor Moody – Director (M.H. Carnegie & Co)

Paul Butler – Director (Former CEO Serene Medical)           

Medical Advisory Board:

James Newman, MD, FACS – Premier Plastic Surgery, Palo Alto, CA

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a non-disclosure agreement (attached hereto as Exhibit A) before they will be given access to key members of the management and intellectual capital teams and the due diligence “war room” documentation (the “Due Diligence Materials”). Each interested party, upon accessing the Due Diligence Materials granted to it, shall be deemed to acknowledge and agree: (i) that it is bound by the bidding procedures described herein; (ii) that it has an opportunity to inspect and examine the Serene Medical assets, to review all pertinent documents and information with respect thereto and raise such enquiries as it considers necessary; (iii) that it is not relying upon any written or oral statements, representations, or warranties of Serene, Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all documents and reports provided to it have been provided solely for the convenience of the interested party, and Serene, 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 Serene Medical assets. Sealed bids must be submitted so that the bid is actually received by Gerbsman Partners no later than Thursday, December 30. 2021, 3:00pm Pacific Standard Time (the “Bid Deadline”).  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 Serene Medical Fixed Asset Schedule may not be complete. 

The structure of any bid will be negotiating a royalty to be paid to Serene based on revenue/the commercialization of the Serene IP. The winning bidder will be notified within 3 business days after the Bid Deadline.   Until a binding sale/royalty agreement is entered into, Serene Medical reserves the right to, in its sole discretion, accept or reject any bid without giving reasons for its decision, withdraw any assets from sale or choose not to proceed with the sale.

Serene Medical will require the successful bidder to close within 7 business days (or such later date as agreed to or notified by Serene Medical at its discretion).  Any or all of the assets of Serene Medical will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.

All sales and transfer taxes, stamp duty, goods and services taxes (GST) or similar taxes, if any, relating to the sale of the Serene Medical assets shall be payable by the successful bidder.

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

Steven R. Gerbsman                                                                             

steve@gerbsmanpartners.com                          

Kenneth Hardesty

ken@gerbsmanpartners.com

Go get your vaccine, especially with Omicron Katelyn Jetelina

It’s important that everyone gets vaccinated. Even with Omicron. Actually, especially with Omicron. This seems counterintuitive given the “vaccine escape” language floating around. But vaccines are still very important. This is why…

First, our house is already on fire.

Our house is already burning from Delta. Transmission is incredibly high in 88% of counties in the United States. We have millions of people unprotected (whether they want to be or not), which is reflected by full hospitals (looking at you, Michigan) and 1,000 vaccine preventable deaths per day. 

We need to address the current fire before Omicron has the opportunity fuel it. We can reduce transmission through masks, ventilation, testing and isolating. Vaccines reduce an incredible about of transmission too (see my previous post here). 

Second, complete immune escape form Omicron is unlikely.

If and when Omicron comes (it’s probably already here) and if it’s a threat (pushes Delta away) that doesn’t mean we are just out of luck. Immune escape is not a binary (yes/no) event. We are not going to start from square one. This is because vaccines and our immune systems are made with mutations in mind. Immune escape is more like corrosion. I’ll attempt to explain…

First line of defense- Antibodies

Vaccines induce something called a “polyclonal response”. Basically, the vaccine instructs the body to generate numerous shaped antibodies that can connect to many different parts of the virus (see picture). Those antibodies are diverse in shape and cover the whole waterfront of the spike protein. 

Mutations to those target sites raise the possibility that the vaccines would be less effective, not necessary that they won’t work at all. Some antibodies may not attach, some antibodies may not attach as tightly, but others will. We saw this with Beta (another Variant of Concern). There were far less places for the neutralizing antibodies to attach, but some still did. 

Omicron has some of the same mutations as Beta and more. Even so, we hypothesize that there is still space for these antibodies to attach. That’s because of evolution competition. For the virus to survive, it has to change enough to outsmart our vaccines but cannot change enough where the virus’s key doesn’t fit at all. If the virus is still using the same door with Omicron (ACE2 receptors), then our antibodies can probably still recognize parts of that key.

Boosters play a significant role here. They restimulate the immune system and increase the number of antibodies so more can attach. To a lesser, but important, extent boosters also generate a much broader level of immunity. In other words, boosters can develop antibodies against more parts of the virus. We saw this in a recent preprint study.

Also, the factories that make antibodies (B-cells) can adapt to new variants. Like a production factory, B-cells can modify their products as needed. So, while antibodies that are generated are highly specific, B-cells can adapt to any variant and create new specific antibodies.

How do scientists test this first line of defense?

Lab scientists in South Africa are currently answering an incredibly important question: Do vaccine-induced antibodies attach given Omicron’s 32 changes? And if so, how many neutralizing antibodies attach and how tightly? To answer this, scientists have to develop and grow a virus in the lab that mimics Omicron. This will take a week or two. But once this happens, blood from vaccinated will be mixed with the virus so we can see how antibodies respond. 

Secondary response

If neutralizing antibodies can’t catch the virus before it infects our cells, then our second line of defense kicks in: T-cells. T-cell protection is harder for viruses to escape because their protection spans virtually the entire spike protein, whereas antibody responses tend to focus on relatively few regions. T-cells wouldn’t necessarily help prevent infection from Omicron, but it would help protect against severe disease and death. 

Scientifically testing the second line of defense

T-cells are hard for scientists to collect and really difficult to work with in a lab. So, lab scientists aren’t currently focusing on Omicron T-cell response.

Instead, population health scientists can jump in and answer: Are vaccines protecting Omicron cases from severe disease? Interpreting real world data is incredibly difficult: 

  • We have to ensure interpretations are not biased. For example, in South Africa, is this case growth because we are actively looking for Omicron? Or is there a true increase in cases? 
  • Disease profiles can lag. Like I posted yesterday, preliminary hospitalization data in South Africa is promising. But we still have a lot of questions. 

If our defense doesn’t work, we already have solutions in the pipeline

Vaccine manufacturer scientists (like Moderna and Pfizer) are tasked to answer: If our vaccines don’t provide as much protection as we would like, then what’s our solution? Several studies already underway with potential solutions: 

1.  Develop a new vaccine that directly responds to Omicron. Unfortunately, this solution would take the most time: develop, test, manufacture, and distribute. It’s not even clear that we need an Omicron specific vaccine.

2.  Use a vaccine formula for another variant of concern. Vaccine scientists already created and tested a Beta-specific booster. Because Omicron has a lot of the same features as Beta, this vaccine has the potential to provide significant protection. We would just need to test it. 

3.  Use a higher booster dose. If our current boosters don’t work against Omicron (and that’s a big if), then a higher dosage of current vaccines may work. For example, Moderna is testing whether a 100 mcg booster (instead of the current 50 mcg booster) is better. This would cut a lot of manufacturing and distribution corners and we could get to this the fastest. 

Bottom Line: Our immune system is an incredible, beautiful, complex, and adaptive system. We also have thousands of scientists around the world working on our questions and on solutions if we need them. Do not delay your booster appointment. Don’t delay your 5-11 year olds second shot. Our house is currently on fire and we need to respond before Omicron has the potential to fuel it.

Love, YLE 

I would like to thank the amazingly brilliant Dr. Miguel Arturo Saldaña, PhD— a virologist and microbiologist that helped me think through these immune system processes and implications for Omicron. On a holiday weekend. 


“Your Local Epidemiologist (YLE)” is written by Dr. Katelyn Jetelina, MPH PhD— an epidemiologist, biostatistician, professor, researcher, wife, and mom of two little girls. During the day she has a research lab and teaches graduate-level courses, but at night she writes this newsletter. Her main goal is to “translate” the ever-evolving public health science so that people will be well-equipped to make evidence-based decisions, rather than decisions based in fear. This newsletter is free thanks to the generous support of fellow YLE community members. To support the effort, please subscribe here:

Subscribe now

Successful ‘Date-Certain M&A’ of Ohana Biosciences, Inc., its Assets and Intellectual Property

Gerbsman Partners is pleased to announce the successful completion of maximizing the value of the Assets and Intellectual Properties at Ohana Biosciences, Inc.

Due to market conditions and trends, the Board of Directors and senior lender made the strategic decision to maximize the value of its Assets and Intellectual properties.

Gerbsman Partners – led by Steven R. Gerbsman, Principal and Kenneth Hardesty (CEO in Residence)– provided the Board of Directors, the senior lender and the assignee for the benefit of creditors of Ohana Biosciences, Inc. with financial advisory leadership through its proprietary ‘Date-Certain M&A Process’, facilitated the sale of the company’s Assets and Intellectual Property and the closing of the sale with other company Advisors.

Specifically, Gerbsman Partners provided leadership with:

1.  Business consulting and investment banking domain expertise in developing strategic action plans.

2.  Implementing its proprietary ‘Date-Certain M&A Process’ in order to maximize value of Velicept’s Assets and Intellectual properties.

3.  “Managing and guiding the process” among potential acquirers, lawyers, advisors, as well as all stakeholders of interest.

About Gerbsman Partners

Gerbsman Partners focuses on maximizing enterprise value for stakeholders and shareholders in underperforming, undercapitalized and undervalued companies and their intellectual properties. Since 2001, Gerbsman Partners has successfully maximized the values of 114 companies in a wide and diverse spectrum of industries, ranging from technology, medical device/life science, digital marketing to cyber security, to name only a few.*

In the process, GP has successfully restructured/terminated over $810 million of real estate executory contracts and equipment lease/sub-debt obligations, and has assisted in over $2.3 billion of financings, restructurings and M&A transactions.*

Gerbsman Partners has offices and strategic alliances in San Francisco, Orange County, Boston, New York, Washington DC, McLean, VA, Europe and Israel.

*For further information on Gerbsman Partners expertise and industry experience, please request our company profile here

Andrea Bocelli and His Daughter Sang an Incredibly Moving Rendition of “Hallelujah” During His Christmas Concert

https://www.msn.com/en-us/music/news/andrea-bocelli-and-his-daughter-sang-an-incredibly-moving-rendition-of-hallelujah-during-his-christmas-concert/ar-BB1bX3mG