A medical device product and process breakthrough in rotator cuff surgery


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We are advancing the quality of life in patients with tendon tears while making surgery easy, fast, and cost effective.

Aevumed is currently on a mission to advance the treatment of patients with rotator cuff tears. The PHANTOM™ suture anchor for rotator cuff repair has been cleared by the FDA for marketing and launch is planned for Q4 2018. The PHANTOM-X™ is a disruptive technology under development and addresses the 20% failure rate of rotator cuff surgeries by providing both the biomechanical support and biological enhancement planned to launch in 2019.

Technological innovations don’t get more exciting than those taking place in the world of healthcare.  Everyday, new biotech breakthroughs are reached that make treatment better, medications more effective, and generally help save lives.  One area that’s lagging a bit behind the others, however, is the alarming number rotator cuff repair re-surgeries. Today, more than 20% of patients return to the operating room because of retears of the rotator cuff. The failure is primarily due to the rotator cuff unable to successfully fuse back to bone. In addition, 54 million Americans, half of all adults age 50 and older, have bone health concerns. In severe cases, the disease is named Osteoporosis and is often called a “silent disease” because you cannot feel your bones getting weaker. With most biotech attention being devoted to pharmaceuticals and treatment devices, technique and product breakthroughs that improve surgery performance aren’t being addressed as much.  Because of it, the efficiency and effectiveness of many operations aren’t being optimized.

One glaring example of this is rotator cuff surgeries.  The averge age of patients going through surgical rotator cuff reapair is over the age of 50 years making more than 50% of those patients have low bone quality. Furthermore, repairing this region of the shoulder requires the use of instruments that tie the tendon to the bone.  To execute this, surgeons currently turn to a combination of lassos, anchors, and sutures that require disposable surgical instrumentation to pass sutures through tendons.  Despite being widely used, this process is extremely time consuming and uses exclusively-disposable devices.  In addition, the time and labor-intensive nature of the surgery introduces higher levels of risk associated with anesthesia exposure and infection.  Here’s a visual representation of the cumbersome 8-step status quo:

The need for rotator cuff process improvement is certainly pressing, on a number of fronts.  Rotator cuff tears are prevalent, and occurring at increasing frequencies - with over 700,000 arthroscopic rotator cuff repair surgeries performed in 2017. Furthermore, governments and insurance companies are feverishly seeking more cost-effective treatment methods to combat rising healthcare industry costs. With the orthopedic biotech market (valued at $34 billion) currently getting significant attention from manufacturers and investors, the time to act is now.

The magic lies in our proprietary suture anchor device called the PHANTOM™, which gives surgeons a variety of intra-operative options when performing arthroscopic rotator cuff repair.  This cost-saving anchor device carries three sutures, reduces the surgical steps from 8 to 4, and utilizes Micro-Thread on its surface - a unique micro-structure technology that aids in pull-out strength by more than 260% than tradition anchors on the market.  

The PHANTOM™ also:

An alternative to other more invasive procedures, arthroscopic surgery allows surgeons to look inside joints (shoulders, knees, etc.) using small incisions to identify problems.  Quite often, surgeons can then correct these problems with fewer disturbances to the joint - and far less recovery time for the patient.  Through the use of the PHANTOM™ , Aevumed is singlehandedly taking arthroscopy to yet another level.  Our rotator cuff breakthrough is even less invasive and less impactful to the patient than even the finest arthroscopic methods.

As is with many things in our field, words can’t do this justice.  Let’s take a visual look at our improved process:

A technology that benefits all three;

  • Patient: Stronger Pullout Strength, Less time, exposure to anesthesia, and possibility of infection
  • Surgeon: Simple and less steps
  • Hospital: Less cost and more efficient

Aevumed has received FDA clearance to market the PHANTOM™ suture anchor in the US. This is a major milestone for the company and we have officially entered our commercialization phase. The PHANTOM™ suture anchor repairs Rotator Cuff tears providing superior pullout strength while saving time for surgeons and reducing costs for hospitals.

Now, we’re focused on securing funds in order to reach the next level - and eventually get the PHANTOM™  in operating rooms everywhere.  Other milestones we’ve reached since our beginnings include:

2nd Product Under Development.  The PHANTOM-X™ is a disruptive technology that addresses the 20% failure rate of rotator cuff surgeries by providing both the biomechanical support and biological enhancement.

Protection on the way.  The legwork has been completed on provisional and non-provisional patents, which will serve as incredibly valuable IP assets.

Key partnerships secured.  We’re building relationships with some of the biotech sector’s more influential players.  Pyxa Solutions, has provide our regulatory filing with the FDA, is one example. 

The puzzle’s coming together.  We’ve made strides in our supply chain, having already contracted manufacturers around the Northeastern US. Packaging and sterilization efforts have also been addressed.

Skin in the game.  Our team’s commitment (and belief in our company) has been established through $305,000 in total capital raised through our own funds and via angel investors.

Aevumed PHANTOM™ Instrument Set

PHANTOM™ Instruments include Awls and Taps for different implant sizes

Aevumed PHANTOM™ Shelf Box and Labeling

Aevumed PHANTOM™ sterile package

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