October 26, 2021 10:17 ET | Source: SpinaFX Medical Inc
Minimally invasive image-guided therapy start-up, SpinaFX Medical Inc. (SpinaFX) is pleased to announce the signing of a commercialization contract manufacturing agreement with StarFish Product Engineering Inc. (“StarFish Medical“), Canada’s largest medical device design, development, and manufacturing services organization.
“SpinaFX is very pleased to welcome StarFish to the SpinaFX team,” commented John Soloninka, SpinaFX’s Chief Operating Officer. “We ran a rigorous process comparing four of the top, highly-recommended medical device design, commercialization and contract manufacturing organizations from across the US and Canada. StarFish Medical’s deep skills and experience, facilities, customer reviews, and willingness to intimately customize and integrate their services with our operations, won the day. The strategic alignment between the companies is excellent!”
StarFish Medical is Canada’s leading medical device design, development, commercialization and contract manufacturing company with ISO 13485 certified engineering and finished manufacturing services. StarFish has partnered with many successful medical device companies to create new innovative technologies across several medical specialties.
Scott Philips, CEO or StarFish commented: “We measure our success through the value we help our clients generate for patients, providers, payers and their shareholders. We select clients that we believe will contribute to our “100×100” objective: 100 clients with over $100M in market capitalization. SpinaFX’s minimally-invasive image-guided procedure promises to reduce the time, cost and complexity of spine surgery for patients with low back pain, one of the largest and most costly cohorts of patients worldwide. This is an extremely important goal, and StarFish is committed to helping SpinaFX travel as far and efficiently on their trajectory as possible.”
“I was very impressed with the quality of responses we received from all competing vendors during our selection process,” commented Jeff Cambra, SpinaFX’s Chief Executive Officer. “With StarFish, we not only see deep skills, and experience in design, quality, regulatory, and manufacturing optimization, but also their strategic business orientation…ensuring that our product lifecycle jointly optimizes clinical, business, financing and shareholder outcomes. With much of the manufacturing to occur in StarFish’s north-west Toronto facility, our organizations will be able to work very closely together. We are excited to transfer manufacturing to StarfFish, and to aggressively pursue our rollout into Canada, EU, FDA and beyond.”
About the SpinaFX Medical
Headquartered in Ontario, Canada, SpinaFX is a medical device company bringing innovative, minimally invasive image-guided treatments to patients with back pain due to herniated discs. Our patented technology provides surgeons an earlier alternative to conventional surgery, using a minimally invasive technique to deliver a controlled Oxygen formulation to the affected disc, safely reducing the herniation and inflammation causing pain. SpinaFX’s Triojection™ product was previously CE Marked under MDD and is undergoing re-certification under MDR. Triojection is not yet approved for sale in the North America, the UK or the EU.
About StarFish Medical
StarFish Medical provides award-winning design, development, commercialization, and flexible manufacturing outsourcing services —100% dedicated to the medical device and life science marketplace. StarFish Medical partners with innovative companies to create and manufacture breakthrough products for a full range of medical specialty areas including: Digital Health, Cardiovascular, Neurology, Urology, Gastroenterology, Otology, Ophthalmology, and In-Vitro Diagnostics. StarFish Medical’s technical expertise includes electronics, mechanical, software/firmware systems engineering, in addition to industrial design and human factors. Regulatory Affairs (RA) and Quality Assurance (QA) consultants at StarFish Medical provide regulatory assistance for FDA, CE Mark and Health Canada submissions. Services include QA support for setting up QMS for start-up companies with implementation at the client’s site, and assisting with ISO 13485 certification audits.
Forward looking Statement
This news release contains predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance, referred to herein as “forward-looking statements”, which are made as of the date of this news release or as of the effective date of information described in this release, as applicable. The forward-looking statements address such anticipated events or occurrences which may include economic factors, industry trends, market demand, and corporate performance and profitability. Forward-looking statements are often identified through words or expressions including “expects”, “anticipates”, “plans”, “projects”, “estimates”, “envisages”, “assumes”, “intends”, “strategy”, “goals”, “objectives” or variations thereof or stating that certain actions, events or results “may”, “can”, “could”, “would”, “might” or “will” be taken, occur or be achieved, or the negative of any of these terms and similar expressions).
All forward-looking statements are based on current beliefs as well as various assumptions made by, and information currently available to SpinaFX’s management team. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections, and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. We caution any person reviewing this news release not to place undue reliance on these forward-looking statements as a number of important factors could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates assumptions and intentions expressed in such forward-looking statements.
Neither SpinaFX nor its representatives undertake to update any forward-looking statement, whether written or oral, that may be made from time to time by SpinaFX or its representatives or on behalf of either of them, except as may be required by law.