Aevumed
A medical device start-up
Presenter: Saif Khalil
Monday, March 12, 2018
Embassy Suites, Chesterbrook, Pennsylvania (directions)
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About

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Aevumed is a medical device start-up, founded by ambitious and energetic medical device professionals in the greater Philadelphia area. The company envisions advancing the quality of life in patients with low bone quality. Aevumed is currently on a mission to develop rotator cuff solutions for patients with bone health concerns and focuses on 12-month development cycles working closely with clinicians and streamlining the regulatory approval process. Aevumed’s first product for repairing shoulder rotator cuff tears is the PHANTOM™ rotator cuff anchor.
What is rotator cuff surgery?
The rotator cuff is a bundle of muscles and tendons that hold the humeral head (the ball of the shoulder) into the glenoid (the cup of the shoulder), and allow the upper arm to mobilize. Through age and wear and tear these tendons can tear away from the bone, causing pain and mobility issues. Rotator cuff surgery aims at re-attaching these tendons to the humeral head, typically by deploying a bone anchor and tying the compromised tendon back securely against the bone using sutures. This procedure is typically performed arthroscopically.
What is the market?
The extremity market, which includes shoulders to finger tips and ankles to toes, is the fastest growing (10% CAGR) in orthopedics and its size is estimated to be over $4B. The overall shoulder market is over $2B and there were over 700,000 arthroscopic rotator cuff tissue repair surgeries in 2016 to serve an aging population. Each surgery spends approximately $1,000 on suture anchors making the suture anchor market size over $700M.
What are the clinical needs: Pullout strength is an important need, especially for the 54 million Americans that have low bone quality. In addition, rotator cuff suturing is relatively cumbersome and time consuming where suture anchors require disposable surgical instrumentation to pass sutures through tendons. Furthermore, the time and labor intensive nature of the surgery introduces higher levels of risk associated with anesthesia exposure and infection.
There is a need for reliability, efficiency, and cost effectiveness.
What is Aevumed’s product?
Aevumed has developed the PHANTOM rotator cuff anchor that addresses the surgeon’s clinical needs as follows:
- Reliability - PULLOUT STRENGTH: PULLOUT STRENGTH: Superior to industry and provides maximized bone purchase (265% stronger) with proprietary Micro-Thread technology especially in osteoporotic bone.
- Efficiency - SUTURE PASSING: Reduces the number of suture passing steps by 50%, reducing surgical time. This passing instrumentation is at no extra cost.
- Cost-Effectiveness – NO ADDITIONAL INSTRUMENTATION/SHORTER SURGERY: Eliminates the need for costly disposable suture passing instrumentation. Estimated cost savings is $400/surgical case.
Who are our competitors?
Arthrex, Smith & Nephew, Biomet, DePuy (J&J),.Tornier, Arthrocare, Ascension Orthopedics.
How much has Aevumed raised?
Aevumed has raised $305,000 from angel investors in equity convertible debt used for R&D and attorney fees.
FDA 510(k) submission filed, provisional and non-provisional patents, patent attorney freedom-to-operate letter, production prototypes, cadaver labs, mechanical testing, manufacturing agreements & packaging and sterilization validation protocols, regulatory submission contract, sales distributor contracts, market introduction plan & forecast.
What capital investment are we currently seeking?
$250k in the current seed round.
Where will this funding be used?
Verification and validation, FDA clearance, attorney fees, payroll, and product launch in early 2018.
What is the investor exit plan?
Buyout by a larger company in 3 -5 years or IPO (market permitting). Potential buyers, not limited to; J&J, Arthrex, Stryker, Zimmer Biomet, Conmed, Smith & Nephew, and Wright Medical Group. Target ROI > 7.

3 Major Issues

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- Considering the company’s current situation, needs and assets, what would be the best way to raise more capital?
- What is the best way to go about finding distributors?
- Would now be the best time to start the development of a new product? Would it be better to wait until the company is profitable?

Program:

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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - Saif Khalil, President and CEO of Aevumed will deliver "Elevator" Pitch to the Group
8:20 - A Panel will address three major issues crucial to helping the Company reach the next level.
9:00 - Open discussion: members and guests
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Slides
None available at this time

Audio
None available at this time

Video
None available at this time

Webcast
Aevumed Webcast 03/12/18
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