SpineOvations Announces Final Safety and Efficacy Results for DiscSeal™ Treatment for Low Back Pain 

SpineOvations Announces Final Safety and Efficacy Results for DiscSeal™ Treatment for Low Back Pain 

Sept 14th, 2020 / Carlsbad, CA — SpineOvations, Inc., a California-based medical device company developing novel, minimally invasive therapies for spinal disc diseases, announced final results of the DiscSeal pilot human clinical study in patients suffering from low back pain (LBP).  At the 180-day end of study endpoint, the primary safety objective was met and final efficacy results showed a clear trend in reduction of low back pain, leg pain and disability.  The study enrolled six patients with low back pain caused by discogenic disease not responding to first-line medical therapy.  Enrollment was at two sites, Australian Medical Research, an affiliate of Sydney Spine & Pain Clinic in Sydney, and Metro Pain Group, an affiliate of Monash House Private Hospital in Melbourne, Australia.  The study’s Lead Principal Investigator is Dr. James Yu, MD, FANZCA, FFPMANZCA, FIPP.

The study demonstrated that the safety, tolerability and adverse event profile of DiscSeal was as expected for this patient population with no safety concerns.  The minimally invasive procedure has been easily and quickly performed by the investigators, with all patients discharged on the day of procedure, as intended. 

The primary objective of the study was to assess product safety over the study duration.  The safety review of the study was managed by an independent medical monitor.  Based on the overall safety results, interim MRI reviews, and study adverse events, there have been no product-related safety concerns.  Two serious adverse events (SAEs) were reported, one was gastrointestinal in nature and the other progression of existing discogenic disease and low back pain co-morbidities.  Both SAEs were reviewed by the independent medical monitor and deemed not to be investigational product or procedure related.  All other adverse events were mild-to-moderate, expected as part of the injection procedure or not related to the device.  “We are very pleased with the safety results of this study.  We developed DiscSeal containing well characterized, biocompatible materials and injected only in diseased discs that were determined to be able to contiguously contain the material.  This was verified by the post-study MRI results, lack of safety-related issues, and final patient safety assessments,” said Dr. Neville Alleyne, Orthopedic Spine Surgeon, Chief of Orthopedics at TriCity Medical Center and Co-Founder of SpineOvations. 

The secondary study objective was to assess product performance in reducing levels of pain and disability from pre-treatment pain levels over a 6-month period.  The final results show a consistent improvement in pain and disability across all six outcomes measures at both the 90- and 180-day time points (visual analogue scale (VAS) low back pain (LBP) and leg pain, Oswestry disability index (ODI), overall health status (OHS), and patient and clinician global impression of change.  

Change from Baseline – Pain and Disability Measures  

Follow-Up from Baseline 90-Day 180-Day
End Point
Average All Patient Values (n=6) 
Average Reduction
(Change/Improvement from baseline)
Average Reduction
(Change/Improvement from baseline)
Low back pain VAS -27% -42%
Leg pain VAS -47% -37%
ODI -16% -8%

Change from Baseline – Overall Health Status  

Follow-Up from Baseline 90-Day 180-Day
End Point
Average All Patient Values (n=6)
Average Increase
(Change/Improvement from baseline)
Average Increase
(Change/Improvement from baseline)
Overall Health Status 55% 68%

DiscSeal treatment was associated with noticeable clinical improvement in back pain, leg pain, functionality and overall health status. 

Additional patient-specific analyses:

  • Effects with Full Treatment
    Five of the six patients had multi-level disc disease at baseline, contributing to their pain sequelae.  However, as a safety precaution, treatment for this initial safety study was limited to only one diseased disc per patient, regardless of the number of pain-generating discs evaluated.  In the study, only one patient presented with single-level disc disease, enabling treatment of the entire pain generating source for only that patient.  For that patient, the pain reduction was 100% at 180 days for VAS LBP, VAS leg pain, ODI.  
  • Responder Group Analysis
    Four patients (66%) met the sponsor definition of ‘responder’ (patients demonstrating pain reductions of 25% or more at 180 days in pain measures).  In this ‘responder group’, VAS LBP reduction was 58%, and VAS leg was 58% reduction.  
  • Average Improvement with Adjustment for Patient with Other Factors Unrelated to Discogenic Pain
    One of the study patients had numerous additional factors and non-related medical events throughout the study that had a marked effect on the efficacy results.  The overall average efficacy improvement for all remaining patients at 180 days with this patient removed was -45% LBP VAS, -38% Leg Pain VAS, -27% for ODI, and +86% for OHS.  

“These results show great promise and at this point indicate a clear trend in pain improvement.  It is also good to see there were no unexpected safety issues,” said Dr. James Yu, Lead Principal Investigator at Australian Medical Research.  He continued, “Back pain management is a complicated clinical discipline.  Patients respond differently to various pain treatments.  It is reassuring to see that a majority of the patients at our clinical site had noticeable improvement in VAS low back pain, VAS leg pain, ODI, or overall health status.  Some of our patients had an improvement across all these measurements.  As these patients have already failed first line, conservative therapy, it is an encouraging sign for DiscSeal’s development as a future viable therapy.” 

“The safety and efficacy results from our initial human pilot study met all of our expectations of success. This pilot study gives hope that DiscSeal could be the first minimally invasive product for degenerative disc disease and other discogenic disease disorders in the U.S. and Europe, following successful regulatory approval by FDA, and CE Mark,” said Niv Caviar, SpineOvations’ CEO.  “The entire medical community is seeking non-opioid, non-drug treatment approaches that can be administered quickly and simply in an outpatient setting and provide long lasting pain relief.  This is the intended product profile of DiscSeal.  Additionally, since all of the study patients had already tried and failed first line conservative therapy, DiscSeal may offer a future viable choice to either back surgery or alternative therapies not approved by the FDA,” added Caviar.    

With the successful outcome of this human pilot study, SpineOvations is now focused on planning for either an EU registration or a U.S. pilot/registration study to initiate within 6-months.  In parallel, the company is exploring strategic partnering or capital funding options to support such study.  The goal is to develop and gain regulatory approval of DiscSeal in an expedited manner.

About DiscSeal
DiscSeal, delivered via a simple percutaneous injection, is an investigational medical device comprised of a patented and proprietary formulation of biocompatible synthetic microspheres and a hyaluronic acid carrier specifically designed for disc augmentation.  DiscSeal is intended to treat the progression and symptoms of internal disc disruption and degenerative disc disease, common causes of low back pain.  DiscSeal is a viscous material that can be injected with a small gauge needle in a rapid manner via a minimally invasive procedure under local anesthesia.

In preclinical studies, DiscSeal injection was well tolerated and remains in the injected disc without extrusion, and the intervertebral disc maintains its anatomically ideal thickness.  DiscSeal utilizes technology from commercially approved materials and products.  DiscSeal was developed with the intent to provide structural support and sealing in diseased intervertebral discs that cause low back pain.

About SpineOvations
SpineOvations is a clinical-stage medical device company focused on developing innovative minimally invasive therapies to treat low back pain. SpineOvations’ DiscSeal technology is patented. SpineOvations was founded by well-known spinal and neurosurgeons. For further information, visit: www.spineovations.com.

Contact Information
Niv Edward Caviar
Chief Executive Officer
ncaviar@spineovations.com

Scott Mortimer
VP, Corporate Development, Marketing
smortimer@spineovations.com

Source: SpineOvations, Inc.

SpineOvations Announces Interim Safety and Efficacy Results for DiscSeal™ Treatment for Low Back Pain

SpineOvations Announces Interim Safety and Efficacy Results for DiscSeal™ Treatment for Low Back Pain

May 26, 2020 / Carlsbad, CA — SpineOvations, Inc., a California-based medical device company developing novel, minimally invasive therapies for spinal disc diseases, announced today interim results of the DiscSeal pilot human clinical study in patients suffering from low back pain (LBP).   At the study mid-point of 90 days, the primary safety objective is being met and interim efficacy results show a clear trend in reduction of low back pain, leg pain and disability.  The study enrolled six patients with low back pain caused by discogenic disease not responding to first-line medical therapy at two sites, Australian Medical Research, an affiliate of Sydney Spine & Pain Clinic in Sydney, and Metro Pain Group, an affiliate of Monash House Private Hospital in Melbourne, Australia.  The study’s principal investigator is Dr. James Yu, MD, FANZCA, FFPMANZCA, FIPP.

Thus far in the study, the safety, tolerability and adverse event profile of DiscSeal was as expected for this patient population with no investigational device-related serious adverse events or safety concerns.  The minimally invasive procedure has been easily and quickly performed by the sites as intended. 

The primary objective of the study is to assess product safety over the study duration.  The safety review of the study is being managed by an Independent Medical Monitor.  “Based on results of the overall safety to date, interim MRI reviews, and study adverse events, there have been no product-related safety events or concerns.   One patient experienced an unrelated serious adverse gastrointestinal event that required treatment and then resolved.  All other adverse events were mild-to-moderate adverse events, expected as part of the injection procedure or not related to the device,” said Dr. Robert Wright, Independent Medical Monitor.

The secondary study purpose is to assess product performance in reducing levels of pain and disability from pre-treatment pain levels over a 6-month period.  The interim results show an improvement in pain and disability across all six outcomes measures (Visual Analogue Scale (VAS) Low Back Pain (LBP) and Leg Pain, Oswestry Disability Index (ODI), Overall Health Status, and Patient and Clinician Global Impression of Change).  One patient experienced an acute pain exacerbation deemed not related to the product or discogenic disease during the study period and was successfully treated.  The data are summarized below both with the full patient cohort and excluding the patient with the recurrent unrelated pain event. 

Change from Baseline (90-Day Interim results)

Pain & Disability Measures
End Point Average % improvement
– All Patients (n = 6)
Average % improvement
– Excluding patient with pain from recurrent unrelated pain event (n = 5)
LBP VAS 27% 32%
Leg Pain VAS 47% 56%
ODI 20% 40%
Other Outcome Measures
Overall Health Status  55% 78%
Clinician Global Impression of Change* 83% 100%
Patient Global Impression of Change* 83% 100%

* Percent of patients slightly to very much improved

Five of the six patients had multi-level disc disease at baseline, contributing to their pain sequalae.  However, as a safety precaution, treatment for this initial safety study was limited to only one diseased disc per patient, regardless of the number of pain generating discs evaluated.  In the study, only one patient presented with single-level disc disease, enabling treatment of the entire pain generating source for only that patient.  For that patient, the pain reduction was 100% at 90 days for VAS LBP, VAS Leg Pain, ODI.  

Additional patient-specific analyses include:

  • Responder Group Analysis: Three patients met the definition of responder (patients demonstrating pain reductions of 25% or more at 90 days in pain and disability measures).  In these patients, pain and disability improved an average of 60% across both VAS pain measures and ODI.  
  • Severe Disc Disease Findings: Two patients met the definition of severe disc disease, defined as Pfirrmann Grade 4 diseased discs.  In these patients, on average pain improved by greater than 62% in both VAS measures and ODI.

“These results show great promise and at this point indicate a clear trend in pain improvement and also support the safety of the product,” said William Taylor, MD, Neurosurgeon, and Chairman of the SpineOvations Scientific Advisory Board. He continued, “What is of most interest is the higher than average results based on specific sub-groups.  Although these results are not statistically powered, they demonstrate clear trends that, if maintained through the course of the study, will guide the clinical design in a larger registration study.” 

“We are very pleased with these results and they give hope to developing a minimally invasive product that could be the first U.S. approved and indicated therapy for Degenerative Disc Disease and other discogenic disease disorders,” said Niv Caviar, SpineOvations’ CEO.   “The entire industry is seeking non-opioid, non-drug treatment approaches that can be administered quickly and simply in an outpatient setting and provide long lasting pain relief.  This is the intended DiscSeal product profile.   Additionally, since all of the study patients have already tried and failed first line conservative therapy, their choice effectively is either back surgery or alternative therapies not approved by the FDA.  What the study has demonstrated thus far, is that DiscSeal may potentially offer a safe and effective solution to reduce pain for patients refractory and non-responsive to standard therapy,” added Caviar.  

The study is ongoing and will conclude after patients have their final visit at 6 months following treatment.  The Company plans to report final study findings to the public in late summer of 2020.

About DiscSeal
DiscSeal, delivered via a simple percutaneous injection, is an investigational medical device comprised of a patented and proprietary formulation of biocompatible synthetic microspheres and a hyaluronic acid carrier specifically designed for disc augmentation.  DiscSeal is intended to treat the progression and symptoms of internal disc disruption and degenerative disc disease, common causes of low back pain.  DiscSeal is a viscous material that can be injected with a small gauge needle in a rapid manner via a minimally invasive procedure under local anesthesia.  

In preclinical studies, DiscSeal injection was well tolerated and remains in the injected disc without extrusion, and the intervertebral disc maintains its anatomically ideal thickness.  DiscSeal utilizes technology from commercially approved materials and products.  DiscSeal was developed with the intent to provide structural support and sealing in diseased intervertebral discs that cause low back pain.  

About SpineOvations
SpineOvations is a clinical-stage medical device company focused on developing innovative minimally invasive therapies to treat low back pain. SpineOvations’ DiscSeal technology is patented. SpineOvations was founded by well-known spinal and neurosurgeons. For further information, visit: www.spineovations.com.

Contact Information
Niv Edward Caviar
Chief Executive Officer
ncaviar@spineovations.com

Scott Mortimer
VP, Corporate Development, Marketing
smortimer@spineovations.com

Source: SpineOvations, Inc.

SpineOvations Completes Patient Enrollment in Clinical Study of DiscSeal™ for Low Back Pain

SpineOvations Completes Patient Enrollment in Clinical Study of DiscSeal™ for Low Back Pain

February 24, 2020 / Carlsbad, CA — SpineOvations, Inc., a California-based medical device company developing novel, minimally invasive therapies for spinal disc diseases, announced today the completion of patient enrollment in the DiscSeal pilot human clinical study in patients suffering from low back pain. As of end of January 2020, all 6 patients have been treated with the investigational product DiscSeal. Australian Medical Research, an affiliate of Waratah Private Hospital in Sydney, and Metro Pain Group, an affiliate of Monash House Private Hospital in Melbourne, Australia are participating in the study.

Thus far in the study, DiscSeal has been well tolerated with no investigational device-related serious adverse events nor safety concerns. The minimally invasive procedure has been easily and quickly performed by the sites as intended.

The purpose of the study is to enroll patients who have low back pain caused by discogenic disease and who have not been adequately treated by first-line medical therapy. The primary objective of the study is to assess product safety over the study duration. The secondary purpose is to assess product performance in reducing levels of pain from the patients’ pre-treatment pain levels over a 6-month period. Data from this pilot study will support larger registration studies in the European Union and the US. The study is managed locally by Australian CRO, Mobius Medical.

Diseases of the intervertebral disc continue to be a major cause of pain, disability, and loss of productivity throughout the world. “Achieving completion of enrollment of the DiscSeal study takes us a step closer toward a new option for patients with pain due to discogenic disease. We are grateful to the participating patients and for the support of our research collaborators. We are also pleased that thus far there have been no identified investigational product related safety concerns associated with the study,” said Niv Caviar, SpineOvations’ CEO.

Dr. Paul Verrills, Clinical Director of Metro Pain Group and study clinical investigator commented, “Our hospital and pain clinic is at the forefront of back pain treatment and research. We continually see a large group of patients who suffer from discogenic disease and have few approved treatment options.” Verrills added, “We are pleased to be part of the study and we found the DiscSeal product was easily and rapidly injected under image guidance.”

Upon successful completion of the Australian pilot study, SpineOvations’ management plans to initiate additional clinical trials to enable European CE Mark and US approvals. The total estimated worldwide market for global orthopedics devices is valued at $34 billion and growing to $44 billion. Currently, patients who fail conservative therapy (NSAIDs, corticosteroids, and epidurals) have no alternative other than invasive surgery such as spinal fusion.

About DiscSeal

DiscSeal, delivered via a simple percutaneous injection, is comprised of a patented and proprietary formulation of biocompatible synthetic microspheres and a hyaluronic acid carrier specifically designed for disc augmentation. DiscSeal is intended to minimize progression of internal disc disruption and degenerative disc disease, one of the most common causes of low back pain. DiscSeal is a viscous material that can be injected with a small gauge needle in a rapid manner via a minimally invasive procedure under local anesthesia.

In preclinical studies, DiscSeal injection was well tolerated and remains in the injected disc without extrusion, and the intervertebral disc maintains its anatomically ideal thickness. DiscSeal utilizes technology from commercially approved materials and products. DiscSeal was developed with the intent to provide structural support and sealing in diseased intervertebral discs that cause low back pain.

About SpineOvations
SpineOvations is a clinical-stage medical device company focused on developing innovative minimally invasive therapies to treat low back pain. SpineOvations’ DiscSeal technology is patented. SpineOvations was founded by well-known spinal and neurosurgeons. For further information, visit: www.spineovations.com.

Contact Information
Niv Edward Caviar
Chief Executive Officer
ncaviar@spineovations.com

Scott Mortimer
VP, Corporate Development, Marketing
smortimer@spineovations.com

Source: SpineOvations, Inc.

SpineOvations Initiates Human Clinical Study of DiscSeal for Low Back Pain

SpineOvations Initiates Human Clinical Study of DiscSeal for Low Back Pain

Press Release November 2019

November 21, 2019 / Carlsbad, CA — SpineOvations, Inc., a California-based medical device company developing novel minimally invasive therapies for spinal disc diseases, announced today that it has commenced clinical study of DiscSeal. The company received Australian regulatory approval to initiate a pilot human clinical study in patients suffering from low back pain and the first patient has been treated with the investigational product DiscSeal at Australian Medical Research, a research facility in Sydney’s Waratah Private Hospital. The study will enroll 6 to 10 patients who have low back pain caused by discogenic disease and whom have not been adequately treated by first-line medical therapy, across two clinical sites in Australia. The primary purpose of the study is to assess product safety over the study duration. The secondary purpose is to assess product performance in reducing levels of pain from the patients’ pre-treatment pain levels over a 6-month period. In the minimally invasive procedure, DiscSeal is administered into the intervertebral diseased disc (IVD) of patients suffering from low back pain under local anesthesia. Data from this pilot study are intended to support larger registration studies in the European Union and the US.

Although, back pain is one of top three reasons for patients to visit a doctor and low back pain is experienced by 80% of people at some point, to date there have been no FDA-approved drugs or non-invasive devices indicated for low back pain caused by discogenic disease. “The successful injection of our first human patient is a watershed moment in the development of the DiscSeal. All of our pre-clinical, scale up, stability and biocompatibility studies supported advancing DiscSeal to human testing for safety and efficacy. We are very pleased to have commenced our human study to develop further scientific and clinical evidence for our product development process,” said Niv Caviar, SpineOvations CEO.

James Yu, M.D. at Sydney Spine and Pain, and Clinical Director of Australian Medical Research is the lead investigator in this discogenic low back pain study. “Discogenic back pain is a very common medical condition and, while many clinical approaches exist, very few are supported by clinical evidence for use in low back pain. It is desirable to be able to utilize a regulatory-approved product that can be injected into the IVD via a minimally invasive manner and provide long term relief for patients. We hope that DiscSeal can be a new treatment option for pain specialists such as myself,” said Dr. Yu.

Upon successful completion of the Australian pilot study, SpineOvations’ management plans to initiate clinical pivotal trials for Europe’s CE Mark approval. A CE Mark approval will enable commercialization in Europe. Further, SpineOvations’ management plans to eventually conduct a US clinical trial after the EU study independently or with a large life science partner. The total estimated worldwide market for global orthopedics devices is valued at $34 billion and growing to $44 billion. Currently, patients who fail conservative therapy (NSAIDs, Corticosteroids, epidural injections) have no alternative other than invasive surgery such as spinal fusion.

About DiscSeal
DiscSeal, delivered via a simple percutaneous injection, comprises a patented and proprietary formulation of biocompatible synthetic microspheres and a hyaluronic carrier specifically designed for disc augmentation, thereby minimizing progression of internal disc disruption and disc degeneration disease, one of the most common causes of low back pain. DiscSeal is a viscous material that can be injected with a small gauge needle in a rapid manner via a minimally invasive procedure under local anesthesia.

In preclinical studies, DiscSeal injection was well tolerated and remained in the injected disc without extrusion, and the intervertebral disc maintained its anatomically ideal thickness. DiscSeal utilizes technology derived from commercially approved dermal fillers and improves clinical performance of traditional bulking, sealing, and hydration of dermal fillers for the intervertebral disc treatment. To date over 30 million Americans and Europeans have been injected with over one dozen commercially approved dermal filler brands.

About SpineOvations
SpineOvations (SO) is a clinical stage medical device company focused on developing innovative minimally invasive therapies treating low back pain. SpineOvations’ DiscSeal technology is patented. SpineOvations was founded by well-known spinal and neurosurgeons and led by experienced executives in the life sciences. For further information, visit: www.spineovations.com.

Contact Information
Niv Edward Caviar
Chief Executive Officer
ncaviar@spineovations.com

Scott Mortimer
VP, Corporate Development, Marketing
smortimer@spineovations.com

Source: SpineOvations, Inc.

SpineOvations Appoints Marc Bellotti to the Board of Directors

SpineOvations Appoints Marc Bellotti to the Board of Directors 
Press Release July 2017
July 19, 2017 /SAN DIEGO — SpineOvations, Inc., a California-based medical device company developing novel minimally invasive therapies for spinal disc diseases, announced the appointment of Marc Bellotti, M.S., to its board of directors, effective immediately. Marc will serve as an independent director and member of the audit committee and serve as Chairman of the Board R&D Committee.

“Marc brings an impressive track record in medical device research and development and executive leadership in large and small companies to SpineOvations and will play a key role guiding SpineOvations as it develops novel minimally invasive therapies for patients suffering from lower back pain,” said Niv Caviar, SpineOvations CEO. “Marc’s experience with successfully managing medical device research and development processes to regulatory approval and commercialization will be an asset to our team as we move forward with the conduct of European CE Mark studies planned to begin early next year.”

Marc Bellotti is currently a partner at Fuel Source Partners, a management consulting and development execution company for the medical device industry. He has more than 35 years of medical device development experience working in both large and small companies. Prior to consulting, Marc was VP Research and Development for Sonendo, Inc. Earlier in his career, he held senior executive positions at Johnson and Johnson and Baxter Healthcare. At Johnson and Johnson, he was Worldwide VP of R&D for Advanced Sterilization Products and a member of the Board of Directors. He is a member of OCTANe and serves on the Launch Pad for new start-ups, is on the Board of Device Alliance, is an EIR at UCI Innovation Institute and is part of the Executive Next Practices Institute. Marc holds both undergraduate and graduate degrees in Biomedical Engineering from Rensselaer Polytechnic Institute and has over 100 patents and patents pending in addition to several publications.

“I am excited to join the SpineOvation’s board,” said Marc Bellotti. “The DiscSeal platform technology has the opportunity to change the way discogenic back pain is treated. The product has the potential to be the first minimally invasive solution for those patients who fail first line therapy for lower back pain and desire an alternative to surgery. Early results with DiscSeal have been very encouraging and I look forward to contributing to the board and working with the management team on the next steps in development as the product advances to human studies.”

The Company’s current board of directors are Neville Alleyne, MD; Marc Taylor, MD; Stuart Young, MD; Bill Nydam; and Niv Caviar.

About DiscSeal

DiscSeal, delivered via a simple percutaneous injection, is a patented, proprietary formulation of biocompatible synthetic microspheres and a viscous carrier specifically designed for disc augmentation, thereby minimizing progression of internal disc disruption and disc degeneration disease, one of the most common causes of lower back pain. In preclinical studies, DiscSeal injection was well tolerated and remains in the injected disc without extrusion, and the discs maintained their disc height.

In early 2018, The company plans to initiate human clinical trials sufficient for EU CE Mark application. The company plans to file for CE Mark after the study, which will lead to potential CE Mark approval of DiscSeal. CE Mark approval will enable commercialization in the EU. The company plans to conduct a US trial after the EU study.

About SpineOvations

SpineOvations (SO) is a mid-stage medical device company focused on developing innovative minimally invasive therapies for the intervertebral disc and lower back pain conditions. SO’s DiscSeal technology is patented. The company is founded by well-known spinal and neurosurgeons and led by experienced executives in the life sciences. For further information, visit the company’s website at www.spineovations.com.

Contact

Niv Caviar, Chief Executive Officer

ncaviar@spineovations.com

Source: SpineOvations

SpineOvations Appoints Bill Nydam to the Board of Directors

SpineOvations Appoints Bill Nydam to the Board of Directors
Press Release June 2016
Jun. 20, 2016 / PRZen / SAN DIEGO — SpineOvations, Inc., a California-based medical device company developing novel minimally invasive therapies for spinal disc diseases, announced the appointment of Bill Nydam, M.B.A., CPA, to its board of directors, effective immediately. Bill will serve as an independent director and member of the audit committee.

“Bill brings a wealth of health care experience to SpineOvations and will play a key role as SpineOvations continues its vision of developing novel minimally invasive therapies for patients suffering from lower back pain,” said Niv Caviar, SpineOvations CEO. “Bill’s expertise and proven track record in the medical device and life science space will be a tremendous asset to SpineOvations.”

Bill Nydam is currently President and CEO of CryoMedix. He has over 30 years of leadership experience in healthcare. He has started several companies, turned around several companies, was the President of Endocare, a publically traded cryoablation company, and managed a venture capital fund. He has created several billions of dollars of shareholder value in his career to date. Bill received his B.S. in Accounting and Master of Business Administration at the University of California at Berkeley.

“I am honored to be selected to sit on SpineOvation’s board,” said Bill Nydam. “I’ve been impressed with the great potential of the DiscSeal platform technology, preliminary in vitro and in vivo efficacy and safety results in addition to the experience of the board and management. DiscSeal has the potential to be the first minimally invasive solution for those patients who fail first line therapy for lower back pain and desire an alternative to surgery.”

The Company’s current board of directors are Neville Alleyne, MD; Bill Taylor, MD; Stuart Young, MD; and Niv Caviar.

About DiscSeal

DiscSeal, delivered via a simple percutaneous injection, is a patented, proprietary formulation of biocompatible synthetic microspheres and a viscous carrier specifically designed for disc augmentation, thereby minimizing progression of internal disc disruption and disc degeneration disease, one of the most common causes of lower back pain. Initial results show that DiscSeal is safe and remains in the injected disc without extrusion, and the discs maintained their disc height.

About SpineOvations

SpineOvations (SO) is a mid-stage medical device company focused on developing innovative minimally invasive therapies for the intervertebral disc and lower back pain conditions. SO’s DiscSeal technology is patented. The company is founded by well-known spinal and neurosurgeons and led by experienced executives in the life sciences. For further information, visit the company’s website at www.spineovations.com.

Contact

Niv Caviar, Chief Executive Officer

ncaviar@spineovations.com

Source: SpineOvations

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