A biotech product and process breakthrough in rotator cuff surgery
We make surgery easy, fast, and cost effective.
At Aevumed, we steer surgical process improvement through biotech innovations – and have a huge one in store for rotator cuff repair. Our new suture anchor device, the PHANTOM™ , helps cut the steps in half for surgeons – lowering risk even more for patients while saving hospitals money. Testing is underway, and FDA clearance is upon us; come join our team before it’s too late!
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 surgical processes. 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. 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. Furthermore, 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 1.7 million surgeries expected in 2016. 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 $30 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, and utilizes Micro-Thread on its surface – a unique micro-structure technology that aids in pull-out strength. The PHANTOM™ also:
The PHANTOM™ allows surgeons to make optimal decisions on the fly – which in turn improves surgical outcomes and patient quality of life. Our team has submitted a Q-sub feedback request to the FDA, and has a strong regulatory partner on board to help us mitigate risk. Now, we just need you!
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:
Getting to market often takes a little longer in the biotech sector, due to high levels of regulation; but nevertheless, the state of the union is strong here at Aevumed. We submitted a Q-sub to the FDA back in December 2015, and received an overwhelmingly positive response three months later. 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 2012 beginnings include:
Testing underway. We’re still waiting on FDA clearance before sales can be made – but we aren’t sitting back. Our own Medical Advisory Board has been busy testing PHANTOMTM prototypes in cadavers.
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, who will 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 $250,000 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