By Tom Ballard, Chief Alliance Officer, PYA
One of the recommendations that start-up advisors tell entrepreneurs is to make sure you keep your investors, potential investors, and other stakeholders fully advised of your progress, and the team at Winter Innovations LLC is a good model to follow.
In a recent update, Co-Founders Lia Winter and Preston Dishner started the email with this simple statement: “We’d like to take a few moments to update you on the exciting progress of Winter Innovations. We performed testing that shows EasyWhip™ is faster than current products on the market, we completed and submitted our 510(k) to the Food & Drug Administration (FDA) for review, we have initiated international patent filings, and we are nearing the close of a round of funding that will enable us to continue achieving milestones.”
They followed-up that quick read with bullets on each point.
- The 510(k) was submitted to the FDA on March 8. “We passed the ‘Refuse to Accept’ administrative check, and a reviewer has officially been assigned to our 510(k) application. We expect to begin interactions with the reviewer within the next two months.”
- Regarding the claim about the performance speed of the device, they wrote that “recent testing completed by health professionals demonstrated EasyWhip™ is at least 25 percent faster to use than two current products on the market today. The testing also demonstrated that stitches created with EasyWhip™ achieve the same biomechanical strength as grafts prepared with existing products.” They thanked orthopedic specialists at Ballad Health as well as The Instru-Met Corporation for their generous assistance with the testing. “Please email us if you would like to receive a copy of the summary test report.”
- On the intellectual property front, Winter Innovations is filing for international patents in selected countries.
- Finally, the Co-Founders said they have agreed on investment terms with a lead investor for the bridge funding round. “We are currently in due diligence with multiple investment groups and anticipate closing the round soon after diligence is complete.” The funding will enable Winter Innovations to achieve what it calls its “key value-driving milestone” – obtaining 510(k) clearance for EasyWhip™.
“As we move forward, we are entering a new phase for the company,” Winter and Dishner wrote. “We are planning to initiate sales efforts once EasyWhip™ receives clearance from the FDA. This means we are working hard to refine our initial launch and go-to-market strategy. With these efforts comes a need for deep expertise. We ask for introductions to those who have experience launching new products in the medical field.”
The company was launched while both Co-Founders were graduate students at the University of Tennessee, Knoxville. EasyWhip™ is a fast, simple, versatile stitching needle for orthopedic ligament and tendon reconstruction surgery.