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Amsel Medical

Amsel provides novel mechanical occlusion devices, for percutaneous, laparoscopic, open surgical, or robotic placement, to provide secure occlusion of blood vessels, ducts, and tubular structures.

Cambridge, MA, USA

One Liner

One Liner
Amsel provides novel mechanical occlusion devices, for percutaneous, laparoscopic, open surgical, or robotic placement, to provide secure occlusion of blood vessels, ducts, and tubular structures.

What Problem We are Solving

Problem
Amsel has identified an unmet need enabled by shortfalls in current solutions and the evolution of the wordwide venous market. All of today’s treatments require destruction or removal of the segments of the diseased vein. This is because they are deployed endoluminally and require an interaction with the vessel lining to occlude. In order to minimize the risk of recanalization and flow being reestablished, large segments of vessel must be destroyed. Current therapies, can take 45-60 minutes, and limit clinic throughput, either destroy or remove the vein. The recovery for the patient can be painful and compression stockings which are extremely uncomfortable. Most importantly reported failure rates have been 50% or greater in advanced diseased perforator veins patients which further burdens the healthcare system. Amsel addresses these pain points through its SCureClamp device which delivers clamping elements across the vessel through a fine needle, with pinpoint accuracy. The clamping elements are nitinol and mechanically lock together, and they compress the vessel from outside the walls, enabling the patient to walk out of the clinic immediately without requiring compression stocking. The deployed clamp provides a vessel occlusion that is very short in length, localized and permanent in duration mitigating recurrences. From a physician perspective, the office-based treatment does not require anesthesia or the purchase of additional capital equipment. It can be performed safely in 10 minutes or less. A much shorter procedure means greater through-put for the physician’s clinical practice. The minimally invasive and secure characteristics of Amsel’s SCureClamp technology also benefits numerous other surgical procedures, as well as Amsel’s government supported trauma solution for junctional and non-compressible hemorrhage. For this trauma injury, application of an external tourniquet is not effective and is associated with a greater than 60% mortality amongst US combatants. With increasing domestic gun violence and terrorism, junctional hemorrhage is also becoming a major cause of morbidity and mortality for civilian victims which Amsel can address.

About Us

About Us
Amsel Medical is a pre-commercial medical device company founded in Cambridge, MA. by world-renowned Vascular Surgeon Arnold Miller, MD. Dr. Miller developed the technology to treat his patient's varicose veins without destroying the entire vein like other treatments do. Amsel has successfully developed its innovative core technology, SCureClamp, earning both FDA and CE Mark Clearance. This unique minimally invasive, mechanical surgical implantable clamping technology is delivered directly through a fine, (1 mm diameter) needle for permanent or temporary occlusion of tubular structures (e.g., arteries, veins, and ducts). The minimally invasive needle delivery results in secure and reliable occlusion. The company is addressing both clinical and military markets. With broad IP protections and successful First-In-Man testing, Amsel has been awarded a $2.5M non-dilutive funding grant through a partnership with the US Air Force to support ongoing innovation of Amsel’s current technology. The new version being developed will reduce front-line battlefield casualty and limb loss due to non-compressible junctional hemorrhage from wounds near the groin, shoulder and neck, where traditional tourniquets and trauma solutions are not effective. Company Highlights: - 15 patents - 3 FDA clearances - CE clearance - First in human clinical safety - $2.5M in ongoing non-dilutive funding - 2023 product launch and revenue Now, Dr. Miller's vision that started out as a minimally invasive clamp to treat veins has a broad range of clinical advantages that can transform the way minimally invasive surgeries are performed.

Venture Highlights

Highlights
Amsel is focused on de-risking commercialization of its technology and make products accretive for a strategic partner. These are our milestones to date:
- 15 patents
- 3 FDA clearances 
- CE clearance
- 3 published articles in peer reviewed medical publications
- First in human clinical safety
- Won 3 US Air Force grants = $2.5M in ongoing non-dilutive funding
- Strong leadership team with medical device startup and commercialization experience
- Expanded word class medical advisory board
- 2023 product launch and revenue

Business Model

Business Model
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.

Competitive Advantage

Quote
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.

Revenue

Revenue To Date
N/A
MRR
N/A
Revenue YTD
N/A
Burn Rate
$150.00

Go-To Market Strategy

Business Strategy
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. 
 

Competitive Analysis

Competitive Analysys
There are currently treatment options for Chronic Venous Disease including thermal treatments from AngioDynamics (laser), Medtronic (Radio Frequency), BD/Bard (Radio Frequency), and a glue from Medtronic.  Again, all these options destroy the vein.  Our most recent comparable was an acquisition of a “me-too” RF system from VENCLOSE by BD/Bard for $290M in 2021.  The SCureClamp offers both a competitive and synergistic option to extend the market potential for current venous treatments with the ability to treat conditions and veins not accessible by other therapies. Amsel’s core clamping technology is not limited to venous disease, as evidenced by its trauma solution, which addresses an unmet need, as well as a wider range of augmentative market opportunities including in laparoscopic and robotic surgery. 
Competitor Website
AngioDynamics www.angiodynamics.com
BD/Bard www.BD.com
Medtronic www.medtronic.com

Networking

Networking
We are open to meeting up to grab a coffee, or just to chat. We would really enjoy your feedback and insight into our venture and would be happy to discuss anything that you are currently working on to see if we can be of service!

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Capital

Loading...
Name Amount
Amount Left $2,400,000.00
Amount Raised (This Round) $2,600,000.00
Amount Raise To Date $10.9M
Type of Raise Convertible Note

Valuation
$15M
Seed Bridge
$4.1M
Total Debt Financing
$4.26M
Grant Dollars Awarded
$2.5M

TAM SAM SOM

TAM
$40B
SAM
$1.5B
SOM
$300M

Business Stage

Business Stage
Series A

Business Type

Business Types
Investor-Backed

Categories

Technology
Healthcare

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