SpinaFX Medical Applauds Clinical Trial Results
SIR Abstract of the Year study highlights promising treatment option for lumbar disc herniation with radiculopathy

TORONTO, ONTARIO, January 17, 2023—Minimally invasive image-guided therapy company, SpinaFX Medical Inc. (SpinaFX), applauds the results of a randomized control trial conducted in Europe that demonstrated non-inferiority of intradiscal oxygen-ozone therapy to microdiscectomy for lumbar disc herniation symptom relief.  

The study, published in Volume 22, Issue 6 of The Spine Journal, was recognized as a 2022 Abstract of the Year at the Society of Interventional Radiology Annual Meeting in June 2022. 

“The study’s findings hold great promise for closing the therapeutic gap in the continuum of care for those suffering with pain due to contained lumbar disc herniation,” said SpinaFX Medical CEO Jeff Cambra. “Back pain is a pervasive issue and expanding use of this treatment option provides hope for millions of sufferers.” 

Key findings of the study include: 

• Both intradiscal oxygen-ozone and microdiscectomy for lumbar disc herniation produced rapid and statistically significant improvements in leg pain, functional disability and quality of life that persisted in follow-up care. 
• Intradiscal oxygen-ozone was non-inferior to microdiscectomy based on overall six-month improvements in mean leg pain scores. 
• Lumbar disc herniation leg pain can be effectively treated with a single intradiscal oxygen-ozone injection.
• Intradiscal oxygen-ozone procedures are quicker than microdiscectomy and patients are discharged significantly sooner. 
• Intradiscal oxygen-ozone therapy can potentially reduce the number of those requiring microdiscectomy for lumbar disc herniation leg pain. 

“I have studied intradiscal ozone for the treatment of herniated lumbar discs for 17 years and believe in the treatment’s potential to fundamentally change the treatment journey of a patient with a herniated disc,” said Dr. Kieran Murphy, SpinaFX Chief Medical Officer and co-author of the study. “This first-of-its-kind study has exciting implications for the future of treatment for suffering patients.” 

The multicenter randomized control trial was administered at three European hospital spine centers. The 49 participants had single level contained lumbar disc herniation with radicular leg pain for more than six weeks that was resistant to medical management. Of the 49 participants, 25 patients were randomly assigned to receive intradiscal oxygen ozone, and 24 were randomly assigned to undergo microdiscectomy. Forty-three patients, or 88 percent of study participants received the treatment assigned to them. The primary outcome that investigators evaluated was six-month improvement over baseline leg pain.  

About SpinaFX
Headquartered in Ontario, Canada, SpinaFX is a treatment solution and technology company bringing innovative, minimally invasive image-guided treatments to patients with back pain due to contained herniated discs. 

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.

CONTACT:
Yuliya Galycheva, Head of Marketing Communications
yuliyag@spinafx.com

TORONTO, Nov. 9, 2022 /PRNewswire/ – Minimally invasive image-guided treatment solution and technology company, SpinaFX Medical Inc. (SpinaFX), today announced the quality management system underlying its Triojection® system has been certified compliant with ISO 13485:2016/Medical Device Single Audit Program (MDSAP) for U.S. and Canada and EN ISO 13485:2016 for Europe. The audit was conducted by Intertek Group Plc and issued no findings.

“This is a foundational milestone for SpinaFX,” said SpinaFX Chief Operating Officer John Soloninka, who led SpinaFX’s ISO/MDSAP certification program. “The achievement is a testament to the high-quality, cross-functional and collaborative effort of our team and our contract manufacturer, Starfish Medical. I sincerely thank all staff and partners for their efforts.”

An internationally recognized quality standard, ISO 13485:2016 is a set of requirements for quality management systems for medical devices. To achieve this independent, third-party certification, companies must demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

“ISO/MDSAP certification is a critical prerequisite enabling our pursuit of Health Canada, EU MDR and U.S. FDA medical device licensing and approvals,” said SpinaFX CEO Jeff Cambra. “This outcome is evidence of the experience and deep capabilities of the SpinaFX team and our partners.”

Headquartered in Ontario, Canada, SpinaFX is a treatment solution and technology company bringing innovative, minimally invasive image-guided treatments to patients with back pain due to contained herniated discs.

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.

SOURCE Spinafx medical inc

SpinaFX Medical to Exhibit at Society of Interventional Radiology Annual Scientific Meeting

Company’s medical advisor will present the SIR 2022 Abstract of the Year

TORONTO, ONTARIO, June 10, 2022—Minimally invasive image-guided therapy company, SpinaFX Medical Inc. (SpinaFX), today announced it will exhibit at the Society of Interventional Radiology (SIR) 2022 Annual Scientific Meeting in Boston, MA, June 11-16, at booth 414. Dr. Alexis Kelekis, medical advisor to SpinaFX, will present the results of a research study on which he was the lead author, recently published in The Spine Journal, on the effectiveness of intradiscal oxygen-ozone treatment compared to microdiscectomy for contained lumbar disc herniation with radiculopathy. This study has been recognized by SIR as one of the 2022 Abstracts of the Year.  

“We are excited to meet with some of the world’s leading interventional radiologists to discuss innovations in minimally invasive, image-guided care and share our recent progress and momentum at SpinaFX” said Jeff Cambra, SpinaFX CEO. “We look forward to Dr. Kelekis’ presentation and celebrate the study’s findings, which have the potential to benefit both patients and providers by addressing a significant gap in the continuum of care for the millions suffering from back pain.”

“I am thrilled that Dr. Kelekis will share the findings of our skilled research team at SIR’s Annual Scientific Meeting,” said Dr. Kieran Murphy, SpinaFX Chief Medical Officer and co-author of the recognized study. “The technology used in this randomized control trial holds great promise for patients struggling with contained herniated lumbar disc pain and it is an honor to have this research recognized by such a prestigious and well-respected organization.”

Dr. Alexis Kelekis will present the results of his study on Wednesday, June 15, at 10:40 a.m. during Closing Plenary.

As an exhibitor during the meeting on June 11-16, SpinaFX will offer attendees the opportunity to discuss the study results and their implications with Drs. Kelekis and Murphy, learn more about SpinaFX and its goal to help develop minimally invasive, image-guided treatment options, and provide input on developing technology with the potential to redefine the treatment of contained herniated discs. Visit SIR’s website to learn more about the Annual Scientific Meeting.

###

About SpinaFX
Headquartered in Ontario, Canada, SpinaFX is a treatment solution and technology company bringing innovative, minimally invasive image-guided treatments to patients with back pain due to contained herniated discs.

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.

CONTACT:
Yuliya Galycheva, Head of Marketing Communications
yuliyag@spinafx.com

TORONTO, ONTARIO, May 26, 2022— Minimally invasive image-guided therapy start-up, SpinaFX Medical Inc. (SpinaFX), today announced significant milestones hit since closing its $6.88M CDN Series A round in November 2021. SpinaFX has leveraged investment proceeds for patent estate expansion, product enhancements, quality management system implementation, regulatory approval pursuits and commercialization of Triojection®. ¹

SpinaFX acquired the world’s largest collection of patents, trademarks, pre-clinical and clinical evidence, and regulatory and commercial documentation surrounding intradiscal oxygen/ozone therapy for treating lumbar disc herniations. Intradiscal oxygen/ozone therapy involves the injection of a mixture of oxygen and ozone gas into an intravertebral contained herniated disc for relief of leg and back pain. 

The acquisition of existing IP yielded a powerful repository of evidence for intradiscal ozone injection involving bench, animal and randomized clinical trial data, as well as 65 patents covering the generation, measurement, delivery, and clinical use of technology for intradiscal ozone injection. SpinaFX is now well positioned to advance its products and accelerate regulatory approval in Canada, the EU, the U.S. and beyond. 

“There is an indisputable gap within the continuum of care for contained herniated lumbar discs,” said Jeff Cambra, SpinaFX CEO. “I am extremely pleased with the confidence placed in the SpinaFX team by investors and to have acquired the collective knowledge of the most impressive companies behind intradiscal ozone technology under the umbrella of SpinaFX. We are moving decisively to bring this technology to market to address the unmet needs of patients and providers.”

Since closing the funding round in November 2021, SpinaFX has achieved several additional key milestones, further positioning the Company to achieve its goal of bringing innovative, minimally invasive image-guided treatments to the global market:

• Built a world-class leadership team, including leading interventional neuroradiologist Dr. Kieran Murphy as Chief Medical Officer
• Acquired existing device finished goods and manufacturing inventory
• Partnered with StarFish Medical for commercialization contract manufacturing support

The Company looks forward discussing these accomplishments with leading interventional radiologists as an exhibitor at the Society of Interventional Radiology 2022 Annual Meeting in June. To learn more about SpinaFX, visit SpinaFX.com.

About SpinaFX
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.

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.

CONTACT:
Yuliya Galycheva, Head of Marketing Communications
yuliyag@spinafx.com

TORONTO, ONTARIO, April 5, 2022

Minimally invasive image-guided therapy start-up, SpinaFX Medical Inc. (SpinaFX), is pleased to announce the appointment of Dr. Kieran Murphy as Chief Medical Officer and member of the Board of Directors of SpinaFX Medical. 

“Dr. Murphy has been a pioneer in the field of intradiscal ozone for the treatment of herniated lumbar discs since 2004,” said SpinaFX Medical CEO Jeff Cambra. “We look forward to drawing on Dr. Murphy’s expertise and leadership in the field as we develop minimally-invasive, image guided solutions designed to address the unmet needs of patients, physicians and health systems.” 

A leading interventional neuroradiologist, Dr. Murphy brings extensive experience to the role, including training at the Royal College of Surgeons in Ireland, residency and fellowship at Albany Medical Center NY, and the University of Michigan. While in his interventional neuroradiology fellowship at University of Geneva in 1996, he became one of the first physicians to perform vertebroplasty. From 1998 to 2008, he was Director of Interventional Neuroradiology at Johns Hopkins University. He is now Professor of Interventional Neuroradiology and researcher at the University Health Network (UHN) in Toronto, the largest academic center in Canada and ranked as the 4 th best hospital in the world by Newsweek. He treats over 300 patients a year at Toronto Western Hospital.

In addition to his clinical and investigatory work at UHN, Dr. Murphy is a prolific inventor who holds 72 patents, particularly in the areas of spine intervention, vertebroplasty and ozone technology. His vertebroplasty devices are used in over 4,500 hospitals worldwide. He has also created and led medical education programs in Ireland, the United States, the Middle East and elsewhere.

Dr. Murphy is the author of 178 peer-reviewed articles (over 6,500 citations) and the co-author and editor of the bestselling textbook Image-Guided Interventions, published by Elsevier. He is a Fellow of the Society of Interventional Radiology and a senior member of ASSR and ASNR. He is an advisor to TVM Capital, Shore Capital and Generation Capital. He also works closely with the Royal College of Surgeons in Ireland in their global surgery training program.

“I’m thrilled to be part of this exciting venture representing a new frontier in the treatment of herniated discs,” said Murphy. “I have worked hard to understand the mechanism of action of ozone on the nucleus pulposus, to build robust devices, and to study the patient benefit in well-structured clinical trials. I believe that SpinaFX will bring effective minimally invasive technologies to market that have the potential to relieve the suffering of millions of patients with symptomatic herniated lumbar discs around the world.”

About the Company
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. 

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 tatements”, 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.

CONTACT:
Yuliya Galycheva, Head of Marketing Communications
yuliyag@spinafx.com

October 25, 2021

25 October 2021, Toronto, Canada: 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.

Website: www.starfishmedical.com

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.

Contact: Yuliya Galycheva, Head of Marketing Communications
yuliyag@spinafx.com

October 15, 2021

SpinaFX Medical names chief operating officer

https://www.massdevice.com/spinafx-medical-names-chief-operating-officer/

October 15, 2021, Toronto, Canada: Minimally invasive image-guided therapy start-up, SpinaFX Medical Inc. (SpinaFX), is pleased to announce the appointment of John Soloninka as Chief Operating Officer. John is a healthtech entrepreneur and ex IBM and Price Waterhouse healthcare system strategist bringing extensive industry, commercialization, regulatory and financing expertise to SpinaFX’s growing team.

John previously served as CEO and co-founder of a $28M public/private venture debt fund, overseeing a syndicated $86M (CDN) investment in 36 early-stage Healthtech companies including Synaptive Medical, CONAVI, SPARTAN, and Profound Medical. Among his several start-ups, John co-founded an AI-based oncology management company, ultimately acquired by Varian Medical Systems, and co-founded and led product development and operations for a cloud-based medical imaging company sold to Merge Technologies of Milwaukee which was ultimately purchased by IBM. 

Designated by the Industry Canada as a “Canadian Investment Champion” John pursued healthcare commercialization initiatives throughout Asia, Europe the US, and Middle East. John’s appointments to research and commercialization advisory posts with the Rotman Research Institute and the Ontario Brain Institute, and as an expert witness to Canada’s Standing Parliamentary Committee on Healthcare, reflect his industry knowledge and stature in this space. Formerly a Professional Engineer, John has a BSc in Engineering Physics from Queen’s University and an MBA with Distinction from the Imperial College Business School, London UK.

Commenting on his appointment, John said: “I am delighted to join the SpinaFX team. Triojection™ has great potential to provide patients with an earlier, simpler back pain procedure, surgeons with a quicker, less-invasive treatment option, and payers with a lower cost per case. Dr. Kieran Murphy, SpinaFX’s Chief Medical Officer, has world-leading expertise in minimally invasive, image-guided technology innovation. Jeff Cambra, SpinaFX’s CEO, has been at the forefront of marketing transformative medical technologies for the global interventional spine market with Medtronic. My background complements these experts and together provides a great foundation to grow SpinaFX.”

Jeff Cambra commented: “John brings an incredible combination of personal characteristics, skills, relevant expertise and strategic insights. His professional training, discipline, and entrepreneurial approach to business is invaluable to SpinaFX’s early-stage commercialization and growth. I am extremely pleased John has chosen to join us.”

About the Company
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.

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.

Contact: Yuliya Galycheva, Head of Marketing Communications
yuliyag@spinafx.com

October 1, 2021, Toronto, Canada:

SpinaFX taps Medtronic, Zimmer Biomet alum as CEO of image-guided pain treatment startup (Link below)

https://www.fiercebiotech.com/medtech/spinafx-taps-medtronic-zimmer-biomet-alum-as-ceo-image-guided-pain-treatment-startup

September 30, 2021, Toronto, Canada: Minimally invasive image-guided therapy start-up, SpinaFX Medical Inc. (SpinaFX), is pleased to announce the appointment of Jeff Cambra as Chief Executive Officer.

Mr. Cambra is a veteran medical device and therapeutics industry executive with an international track record managing product development, commercialization, product portfolios and mergers and acquisitions, with a strong focus on interventional spine technologies and biologics. Jeff spent 12 years at Medtronic, most recently as Vice-President, General Manager of the Interventional Therapies business. For Medtronic, he led a successful turnaround of their $400 million vertebral augmentation and oncology business through new technology innovation, strategic partnerships, acquisitions and expanding margins.

Jeff most recently served as the Vice President of Zimmer Biomet, leading product management for their $5 billion global reconstruction business. Earlier, Jeff spent 13 years with Wyeth Pharmaceuticals (now Pfizer) in numerous leadership roles. Jeff is well positioned to lead SpinaFX on its mission to bring innovative medical solutions to millions of patients globally who suffer from back pain. 

Commenting on his appointment Cambra said: “I’m excited and honored to join SpinaFX bringing its novel medical treatment for back pain to market. With my passion for the interventional space, I constantly assess and monitor multiple promising technologies – I recognized the breakthrough potential of SpinaFX’s technology over a decade ago. SpinaFX is an excellent opportunity to leverage my experience in the medical device field to deliver value for our patients, our customers, and our shareholders.”

Dr. Kieran Murphy, SpinaFX Chief Medical Officer, stated: “Based on early clinical use, and clinical trials results, I believe SpinaFX’s technology has the potential to revolutionize treatment options for patients across the globe who suffer from debilitating back pain, and I welcome Jeff leadership in bringing our new treatment therapy to market. Jeff’s been a colleague and a friend for over 15 years, and I’ve had the pleasure to work with him on many occasions on such matters as product development and product rollout, and related recommendations and advice to senior management of industry participants. He is extremely knowledgeable, customer focused, understands unmet needs and is dedicated to commercializing technologies that have helped benefit so many of my patients. 

About the Company
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.

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.
Contact: Shailla Seth, Marketing Communications, SpinaFX Medical Inc.

shaillas@spinafx.com | spinafx.com
1-(416) 904-7384 | 1-866-323 9004