ClearCam Year in Review - 2020
2020 was an important and productive year for ClearCam, despite the significant challenges our larger society was confronting with COVID-19. Our thoughts are with the individuals and communities, including our fellow healthcare workers and first responders, most heavily impacted by this pandemic.
ClearCam, in its 3+ year existence, has been dedicated to innovative research and development, fiscal prudence, and rapid execution. Despite this unprecedented global crisis, I am pleased to report that we held fast to those guiding principles in 2020.
Kelling
One year ago, on February 20th, Kelling was cleared for human use by the FDA. This allowed us to enact our 2020 plans. Namely, we had to build a validated manufacturing process, an inexpensive (but gold standard) quality system, and initiate our go-to-market plan for this, and future, products.
We also needed to increase our investment in IP and R&D as our long-term product strategy involved Kelling 2.0 and Galaxie, our robotic product. To accomplish this, we raised a successful Seed Series "2" round.
Validated Manufacturing
In January of 2020, in anticipation of FDA Clearance, we leased a 1000 sq. ft Class 8 Cleanroom at ACC's Bioscience Incubator. We qualified, validated, and began production in that controlled environment, and in August 2020, we received our first manufactured Kelling products cleared to use in humans, of the 800 that have been manufactured.
Quality System
Our paper-based Quality System is currently being audited internally, and it forms the backbone for all we do in the company.
Go-To-Market
In September 2020, Dave Poirier, ClearCam’s VP of business development, observed and helped facilitate our first in-human cases in Houston. As of February 11, 2021, the Kelling device has been used in 74 cases, 10 hospital networks, 17 different procedures, and with 22 surgeons. Pediatric, Thoracic, OB/GYN, and General Surgeons are all expressing real interest in going forward with the device.
Intellectual Property
In total, eleven (11) patent applications were filed in 2020 on inventive subject matter directed to the ClearCam-developed innovations. A US patent application directed to system-assessment and control of lens cleaning functionality in robotic surgical systems (Galaxie Project) was prepared in 2020 and subsequently filed in January of 2021.
R&D
ClearCam’s Robotics Product Engineer, Alex Cohen, leads our engineering efforts in the Galaxie Initiative. This includes software and hardware proof of concepts, currently advancing to the prototype stage, as well as speed-of-light execution on Sure-Fit Clips to allow for the perfect fit on a scope every time. The Kelling 2.0 handle and actuation work are rapidly advancing, targeting an early 2021 launch.
Clinical Response
The clinical experience reports with the Kelling device have been very positive. We executed a “slow roll out” to identify any opportunities for improvement in the product or how it was being used. This paid dividends. We identified that we needed a more explicit training program, which was implemented, and were able to make a subtle modification to the product to allow the clinician to effectively use it consistently.
Since then, we have had great results with reliable functionality and surgeon satisfaction. The 74 cases among over 20 physicians and varied hospital systems is no small feat in the middle of a pandemic which has limited elective surgery and restricted access to hospitals. We are hard at work continuing our momentum into 2021, pivoting from manufacturing and doubling down on our engineering, research and development, commercialization, and IP.
We expect continued good results throughout 2021, and look forward to reporting outcomes as we encounter them.
