Amsel Medical plans to leverage its patented technology in three distinct verticals including: 1.) sales of venous product (2023), 2.) sales to the military; leveraging DoD supported non-dilutive funds and Amsel’s sole source designation 3.) licensing technology to strategic partners or build out deep product portfolio.  This strategy allows us to focus on the venous market for which the management team has intimate knowledge as well as partnership opportunities for risk diversification with strategics and the military.

 

The Amsel Medical SCureClamp, which has 15 issued and allowed patents, is a mechanical solution that can be delivered percutaneously making it a simpler, faster and less invasive procedure. It is the only treatment procedure for varicose veins that does not destroy or remove the vein.  The SCureClamp mechanical action extends the forces in the tissue without crushing or destroying it, thus preserving the targeted vessel while eliminating the risk associated with surgery.  Amsel provides an opportunity for a minimally invasive rapid and locally deployed clamping device that mechanically closes the vessel and enables the patient to walk out minutes after treatment without dependence on an inflammatory reaction in the vessel lumen for permanent clamping.

 

Success will be achieved by offering an innovative approach to current thermal, gluing, or surgical stripping methods overcoming key inherent limitations.  All other procedures either remove or destroy the vein.   The SCureClamp interdigitation mechanical tissue clamping attaches tissue in a minimally invasive atraumatic manner and is delivered through an 18G needle (≈1mm).

 

Direct sales of our clamp for treating chronic venous disease (CVD) will be made to 5,000+ vein centers. These are free standing centers that are already called on by independent distributors and allows Amsel to break into the market without the need for a dedicated sales team. These vein centers are predominantly run by Vascular and General Surgeons that are also usually on staff at the local hospitals. We invasion the office-based physician introducing the Amsel product to the local hospital which would eliminate the need for the reps to cold call on the hospital. The Amsel management team developed the market leading endovenous laser system at AngioDynamics and has strong relationships with Key Opinion Leaders (LOL’s).  We have selected KOLs in 12 sites globally as early adopters. They will drive clinical use experience, present at scientific symposia and publish to build awareness and customer acquisition.  Our first full year goal is to establish our 1st  - 50 centers averaging just 2 procedures per week for $4m in reorders.  U.S. sales will achieve a gross margin exceeding 85%.

 

Amsel is also engaged with the U.S. DoD through a non-dilutive grant to develop a new version of its technology to be a temporary occluder, SCureTO while achieving a sole source supplier designation. Deaths associated with junctional and non-compressible hemorrhage in the battlefield prior to surgical intervention are extremely high, with a greater than 60% mortality amongst US combatants. Junctional and non-compressible hemorrhage due to trauma is also a major cause of morbidity and mortality for civilian victims, so the ability to rapidly reduce blood loss and improve survival, while reducing metabolic impacts from ischemia has broad significance. Amsel, supported by non-dilutive DoD funding is leveraging the atraumatic clamping aspect of its device in an adjustable embodiment that is deployable upstream of the injury site like a “vessel specific torniquet” and limits downstream blood flow while enabling some periodic profusion, to reduce limb loss and other metabolic complications.

 

Amsel’s technology also addresses a deep pipeline of applications such as in laparoscopic and robotic surgery.  The company believes these applications can be monetized via strategic partnerships including licensing, distribution, or investment opportunities.

Amsel’s Interdigitating Occlusion Technology (iDOT) is novel in that it enables percutaneous or open delivery of a mechanical clamp through a delivery system as small as an18-gauge needle.  In a manner that has not been possible until today.  At the same time, the interdigitating mechanical tissue clamping represents a new approach to attaching and clamping tissue that is atraumatic. The attachment is dependable as it does not require the formation of a staple in the tissue, has a very small delivery footprint, and does not necessitate the excision of tissue around the vessel at the deployment site. The clamp is deployed across and through the vessel preventing displacement from the vessel.  The clamp provides adaptive compression on tissue of variable thickness (from fine veins to the Left Atrial Appendage) and avoids leakage issues due to changing tissue thickness overtime.  Aside from a small post, it does not injure the compressed tissues minimizing necrosis. 

 

The Amsel Medical SCureClamp, which has 15 issued and allowed patents, is a mechanical solution that can be delivered percutaneously making it a simpler, faster and less invasive procedure. It is the only treatment procedure for varicose veins that does not destroy or remove the vein.  The SCureClamp mechanical action extends the forces in the tissue without crushing or destroying it, thus preserving the targeted vessel while eliminating the risk associated with surgery.  

 

Amsel’s SCureTO utilizes the same clamping elements of the permanent SCureClamp but has a tethering mechanism attached to the clamping elements which allows the SCureTO to be removed when no longer needed without the need for any open surgical procedure. Additionally, the degree of clamping is adjustable and enables variable and controllable blood flow in the vessel to prevent local and distal clot formation and the associated metabolic effects of distal ischemia. This then provides similar benefits to that of an externally applied tourniquet but in a much more targeted manner, and in regions not accessible by a traditional tourniquet.

Although the company is presently pre-commercial, we anticipate product in the market in 2023. The Amsel management team which also founded and built AngioDynamics has done this before, successfully developing and introducing the market leading endovenous laser system into the venous market.   During that time, the team built a dedicated sales organization for this market and developed strong relationships with most key thought leaders. 

 

Amsel’s SCureClamp has been presented at multiple venous specific scientific symposiums around the world and has already generated great interest with physicians.

 

Our strategy for marketing Amsel’s device will leverage our intimate understanding of the venous market and our strong relationships with Key Opinion Leaders .  There are 5,000+ vein centers in the United States and we have selected KOL’s at limited sites globally as early adaptors.  They will drive clinical use experience, present at scientific symposia and publish to build awareness and customer acquisition. These customers will be serviced through a team of independent 1099 sales reps that are currently servicing and have relationships within these free standing OBLs.

 

For trauma, Amsel already has the US Air Force  Special Operations Command as a customer, and has been awarded sole source supplier designation. We plan to expand sales within the DOD and to NATO and civilian markets. Several former executives from Z-Medica (a leader in hemorrhage control products) have joined Amsel Medical as advisors to apply their vast experience in DOD sales and existing channels to navigate the procurement process.