AlloSource Announces Two Presentations On ProChondrix At The International Cartilage Repair Society World Congress

CENTENNIAL, Colo.April 10, 2018 /PRNewswire-USNewswire/ — AlloSource, an organization dedicated to advancing the science and use of transplantable allogeneic cells and tissue, today announced that clinical and scientific data on its ProChondrix® osteochondral allograft will be presented at the International Cartilage Repair Society’s 14th World Congress on Wednesday, April 11 from 13:00-14:00 in the Almaty 3 Room.

Dr. Vishal Mehta will present his 24-month clinical experience with ProChondrix in the knee. Dr. Mehta performed the first ProChondrix implantation in December of 2014 and will share his clinical experience with the product.

“ProChondrix has been a valuable addition to my cartilage restoration treatment protocol and my patient outcomes have been encouraging,” said Dr. Mehta. “I look forward to sharing these clinical results with the international cartilage community.”

AlloSource’s Chief New Ventures Officer, Peter Stevens, PhD, is presenting on “ProChondrix CR Post-Cryopreservation Cell Viability and Basic Science.” AlloSource’s research demonstrates that ProChondrix CR contains viable and metabolically active cells that are comparable to fresh osteochondral allografts. The cryopreservation technology ensures cellular viability for a longer period of time than many osteochondral allografts available today.

“This study demonstrates our commitment to advancing the science behind biologics,” said Stevens. “Our proprietary process enables us to provide a cryopreserved graft that maintains cellular viability with a longer shelf-life, allowing ProChondrix CR to help more patients return to an active lifestyle.”

ProChondrix CR is a laser-etched, cryopreserved osteochondral allograft that helps deliver the necessary components for articular cartilage restoration. This next generation of cartilage restoration therapy provides the viable cells and other biological components necessary for repair and regeneration of damaged cartilage tissues.

About AlloSource
AlloSource is dedicated to advancing the science and use of transplantable allogeneic cells and tissue through pioneering research in regenerative therapies. The organization offers life-saving and life-enhancing solutions in orthopedic, spine, burn and wound procedures to help restore patient health and mobility. As a world leader in cell-based products, fresh cartilage tissue for joint repair and skin allografts to help heal severe burns, AlloSource’s products bridge the proven science of allografts with the advanced technology of cells. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org.

Media Contact:
Megan Duggan
AlloSource
720. 382. 2766
mduggan@allosource.org

SOURCE AlloSource

Related Links

http://www.allosource.org

 

OrthoSpineNews Interview with Mark Foster, President and Chief Commercialization Officer at Trice Medical

Good afternoon Mark, thank you so much for talking with us today. We really appreciate you taking the time. Would you mind giving us a brief introduction and sharing a bit about your background? 

Sure thing. I am the President and Chief Commercialization Officer here at Trice. I have been here for a little under two years and before that was at Smith & Nephew for 8 years. My last role at Smith & Nephew was Vice President of U.S. for their Sports Division. Before that I was at Boston Scientific for 8 years, and I graduated from the University of Richmond.

Mark, we’ve seen a lot of buzz around the mi-Eye 2 lately. What originally prompted the creation of this innovative technology? 

As you may know, there have been some other technologies that took a swing, if you will, at in office arthroscopy. Unfortunately, they may have been a little ahead of their time. They basically tried to miniaturize a traditional arthroscopy tower, which still leaves you with a high capital cost, reusable components and multiple steps to set up; all of which make it hard to adopt in a busy office setting. So, the mi-eye was founded by asking the question- “Can we take a needle and put optics on it?” We started with a totally different view of the market compared to what had already been tried. Essentially, we took a 14-gauge needle and put optics through it, allowing us to deliver a high-quality image in a fully disposable product, that can be used readily and quickly in an office setting.

The mi-eye 2 is actually our 3rd generation camera that has hit the market. As you know, the chips have gotten better and better, as well as more cost effective. We have come to a point where you can finally get an operating room type image, in a disposable needle, at a cost-effective price. This image gives patients instant answers because it is used by the physician in the office.What do you see as the biggest value of the mi-eye 2 to the various stakeholders involved? 

Well, it is the first product I’ve been around that can bring major value to the three main stakeholders involved in the healthcare environment.

Patients: Consider yourself a patient with a torn meniscus or labrum, most physicians know from your physical exam that you’ve got some pathology. Yet in today’s world, you still have to go get that MRI. So, you have to take another day off of work, add an additional office visit, and so on which gets expensive and time consuming. Because the mi-eye was designed to be used in the clinical setting, it saves the patient a tremendous amount of time and money. Or, imagine you are the patient that has had a negative MRI and still has lingering knee pain. I have been in those cases and seen the relief on a patient’s face when the surgeon shows them cartlidge damage on the tablet and let’s them know that they “weren’t crazy.” They can then confidently move forward with treatment.

Physicians: Our surgeons use the mi-eye 2 not only because of the value to the system. They love the fact that they can get a dynamic view inside of the joint by using the camera in the office. The MRI’s are a wonderful tool, but they are a static image of the body at one point in time. The mi- eye allows the physicians to literally have their eye inside of the patient to achieve dynamic diagnostics. Additionally, they can confidently deliver biologics under direct visualization through the lumen of the needle.

Providers: Often times, something that is great for patients might be very expensive. Or if it’s great for the system, maybe it doesn’t fit a clinical need of the physician. In this case, we have peer-reviewed data supporting the fact that for intra-articular pathology, the mi-eye performed on the initial patient visit is the most cost-effective way to manage their imaging needs.

To that point, how does the mi-eye compare with the other options that are on the market? 

Well we don’t really have true, comparable competitors in the market at this time. Our real cost competitor is the MRI. Looking at our device in a single day setting, compared to the amount of time, office visits, MRI costs, and MRI reads, we are really in a great spot. As I mentioned earlier, the mi-eye provides incredible value to all parties involved. However, the MRI and Ultrasound will never and should never go away. They are wonderful tools and will always have a place. The mi-eye is just another great diagnostic option for today’s busy surgeon.

What are some of the other things you are excited about as you look at what’s ahead for Trice? 

We are really excited about getting the CE mark two weeks ago and getting Health Canada approval. In many countries around the world, it can take weeks or months to get MRI’s so we really have a great value proposition outside of the U.S.

We are also excited about the expansion of indications. We’ve seen recon physicians using mi-eye to determine partial vs total knee candidates. We’ve seen trauma physicians using it to confirm fracture reduction. And most recently, we launched our hip camera and the ability to get additional information inside of the hip while delivering an injection, or potentially removing the need for fluoro, is really quite powerful.

Well Mark we really appreciate you spending some time with us and giving us some keen insights into the mi-eye 2. Congratulations on all of the success and we are looking forward to what lies ahead! 

Thanks guys, hope you have a great rest of your day.

 

More Information:

Trice Medical 

 

Paragon 28® expands its JAWS™ Nitinol Staple offering to address corrections of the midfoot and hindfoot

ENGLEWOOD, Colo.April 9, 2018 /PRNewswire/ — Since its inception, Paragon 28® has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28® has launched innovative products and instrumentation to help streamline medical procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

Paragon 28® designed the JAWSTM Nitinol Staple System for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.

The JAWSTM Nitinol Staple System uses superelastic nitinol and a simple insertion method to gain rigid compression across an osteotomy site. Unlike many competitive implants, the JAWSTM Nitinol Staple System has a lightweight titanium inserter that allows the surgeon to fully seat the staple before it is released from the inserter.  This eliminates the need to tamp following insertion which can crush bone surrounding the legs weakening the construct.

Compression is achieved upon insertion; no heating or electrical activation is required.

A low profile bridge helps minimize soft tissue irritation while the sharp-tooth geometry increases pull out resistance and helps resist migration during healing. Paragon 28® optimized the shape, angulation, and size of the staple legs to distribute compression evenly along the length of the legs. This helps to eliminate plantar gapping and ensures consistent force across the osteotomy site.

All instrumentation for the JAWSTM Nitinol Staple System comes in a self-contained, disposable, sterile kit. The JAWS TMNitinol Staple comes pre-loaded on the inserter to help facilitate a quick and simple surgery. An auxiliary instrument set is also available which includes trial sizers, instrumentation used for decortication and the JAWSTM Compressor. The JAWS™ Compressor is available to assist the surgeon in gaining pre-compression in midfoot to hindfoot fusions.

The JAWS TM Nitinol Staple System now offers surgeons 8 mm Straight and Angled, 10 mm Straight and Angled, 15 mm Straight, 18 mm Straight, 20 mm Straight, and 25 mm Straight options to address a multitude of indications throughout the foot.

Product Page: http://www.paragon28.com/products/jaws-nitinol-staple-system/

CONTACT: Jim Edson, Vice President of Product Management and Marketing, jedson@paragon28.com

 

SOURCE Paragon 28

(PRNewsfoto/Paragon 28)

Related Links

http://www.paragon28.com/products/jaws-nitinol-staple-system

OrthoPediatrics Corp. Announces Sponsorship of 2018 EPOS Meeting and Lunch Symposium

WARSAW, Ind., April 09, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, today announced it will continue its Diamond sponsorship for the 37th Annual European Paediatric Orthopaedic Society (EPOS) meeting, which will take place April 11 – 14 in Oslo, Norway. OrthoPediatrics has been a leading sponsor of the Society since the Company’s inception.

At the meeting, OrthoPediatrics will also sponsor a lunch symposium titled “Management of Open Fractures in Children”, featuring a panel of key opinion leaders from around the world. The panelists will discuss the most frequent types of fractures, guidelines for antibiotic use, evidence-based surgical treatment and the management of soft tissue injuries in open fractures in children.  The panel will be moderated by Dr. Pierre Journeau, with additional discussion and case presentations by Drs. Annelie Weinberg, Manoj Ramachandran, and Manon Bachy.

OrthoPediatrics’ President & CEO Mark Throdahl, commented, “We are pleased to continue our leading support of EPOS, one of the world’s largest pediatric orthopedic scientific organizations. This society has remained steadfastly dedicated to elevating the quality of care for children with orthopedic conditions. OrthoPediatrics has shared this mission since our inception, and so we are proud to continue supporting the clinical education of pediatric surgeons as we work together to improve the lives of children with orthopedic conditions around the world.”

About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 24 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 37 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

Ortho Sales Partners Announces the Addition of Chris Lyons as Vice President of Exit Strategy

Ortho Sales Partners, the global leader in commercialization services for the orthopedic industry, is pleased to announce a tremendous addition to the executive team. In an effort to serve clients from inception through exit, Ortho Sales Partners has recruited Chris Lyons to serve as its Vice President of Exit Strategy. Mr. Lyons will be a vital component of any client’s project as he will help create and guide the overall strategy and work on client’s behalf during possible transaction discussions.

Mr. Lyons career began at Smith and Nephew in 1989. While at SNN, he held numerous marketing roles, driving product launches, engaging surgeons, and creating intellectual property predominantly in the companies Knee and Hip product lines.  Additionally, he spent two years in the Smith and Nephew Sales Force to learn the underpinnings of what made the organization successful.

In 2005, Chris joined Medtronic Spine and Biologics, with the first three years being focused on driving growth of the International biologics business of Medtronic.  The opportunity presented itself to move into the realm of Business Development where he served the past 10 years. During this time, Mr. Lyons worked with all of the executive and cross functional leadership to transact various acquisitions, minority investments, as well as license and distribution agreements.  Chris was also selected to join the Board of the Southeast Medical Device Association (SEMDA) of which he remains a contributor, also serving as Chairman of the board for SEMDA for 2016.

With a highly driven, passionate, and entrepreneurial spirit, Chris is excited to be joining the ranks of Ortho Sales Partners as Vice President of Exit Strategy to assist this growing team of industry experts to influence positive commercialization and exit outcomes for Med Tech and Device companies. Chris will work closely with Venture Capital, Private Equity  and other companies focused on successfully exiting. Chris can provide Strategic Guidance, Gap Analysis, M&A consultation and will help implement general strategies that help the shareholders to maximize their return during due diligence and negotiations.

About his new role, Chris Lyons said: “The power of Ortho Sales Partners is their leadership. They have developed a game changing business based on integrity to positively influence better outcomes for medical device companies, which in turn has the possibility to influence greater innovation and healthcare delivery to the market in a timely manner.  I am excited to be part of this team of industry experts.”

“Chris Lyons is extremely well respected and we are thrilled that he has chosen to join our team of the industries most talented and experienced leaders. Ortho Sales Partners continues to demonstrate its commitment to excellence and our team has just gotten demonstrably stronger. We are now able to help companies successfully navigate from early commercialization through exit.” Said Kevin McGann, CEO of Ortho Sales Partners.

About Ortho Sales Partners

Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations and produced results that have profoundly impacted each client’s business.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis from industry stalwarts from some of the highest growth companies.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US. (http://www.orthosalespartners.com).

 

SI-BONE, Inc. Hosts ISASS 2018 Sacroiliac Joint Workshop led by David Polly, MD, Bengt Sturesson, MD, Peter Whang, MD and Brad Duhon, MD

SAN JOSE, Calif.April 9, 2018 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered minimally invasive surgical (MIS) treatment of the sacroiliac (SI) joint with the iFuse Implant System® (“iFuse”) announced that the company is a Silver Sponsor of the International Society for the Advancement of Spine Surgery (ISASS) 2018 Annual Conference in Toronto and will host an educational lunch workshop on the latest developments in diagnosis and treatment of the SI joint including recent commercial insurance coverage policies for MIS SI joint fusion with iFuse.  The workshop will take place on Thursday, April 12th from noon to 1:30 pm in Room 801A and will feature presentations by leaders in the field of spine surgery: David Polly, MD – University of Minnesota, Bengt Sturesson, MD – Angelholm Hospital in SwedenPeter Whang, MD – Yale School of Medicine and Brad Duhon, MD – University of Colorado.

“Leading the session are four distinguished and highly respected academic spine surgeons from the U.S. and Europe with decades of experience diagnosing and treating patients with SI joint disorders,” said Tony Recupero, Chief Commercial Officer at SI-BONE.  “We encourage ISASS attendees to participate in the SI joint lunch workshop to learn about the latest developments in SI joint fusion, progress on diagnosis and important commercial insurance coverage updates.”

In addition to the workshop, SI joint diagnosis and treatment will be the focus of eight podium presentations, including a one-hour symposium, which will be part of the ISASS 2018 scientific program:

Wednesday, April 11th:

1.      2-year Outcomes after Minimally Invasive Sacroiliac Joint Fusion or Conservative Management; Results of a Randomized Controlled Trial
Speaker:  B. Sturesson
8:15 am, Hall F

2.      3-year Outcomes after Minimally Invasive Sacroiliac Joint Fusion:  Prospective Multicenter Study
Speaker: P. Whang
9:28 am, Hall F

3.      Patients with Sacroiliac Joint Pain have Slower Walking Speeds and Shorter, Wider Gait than Healthy Controls
Speaker:  S. Kutz
10:30 am, Hall F

4.      Fixation of the Sacroiliac Joint:  A comparative anatomical analysis of the Lateral and Posterolateral Trajectories
Speaker:  B. Cheng
5:51 pm, Room 803B

5.      Coupled Translational Movements of the Sacroiliac Joint: An In-vitro Study
Speaker:  K. Odeh
5:53 pm, Room 803B

Thursday, April 12th:
6.      Neuromuscular Activity during Gait in Patients with Sacroiliac Joint Pain Compared to Healthy Controls
Speaker:  J. Cox
10:55 am, Hall F

7.      Symposium 3: The Sacroiliac Joint – The Pathway from Pain to Treatment
Moderators: M. Lorio, F. Phillips
5:00 pm – 6:00 pm, Hall F

Friday, April 13th:
8.      Off-Axis Rotation of the Sacroiliac Joint: An In-vitro Study
K. Odeh
2:45 pm, Hall F

Conference attendees can visit SI-BONE booth #400 to learn more about the latest advances in SI joint diagnosis, treatment and insurance coverage for SI joint fusion using the iFuse Implant System.

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5  SI joint dysfunction is often misdiagnosed and the resulting pain can be incorrectly attributed to other causes.  SI joint dysfunction can be identified when a patient points to the source of their pain directly over the posterior superior iliac spine (PSIS), known as the Fortin Finger Test6, combined with a number of positive provocative maneuvers that stress the SI joint and elicit pain, followed by image-guided diagnostic injections to confirm the diagnosis.  The SI joint is the largest of the eight major joints in the human body and the last to have a proven surgical treatment.  The iFuse Implant, first FDA-cleared in 2008, is the only device for treatment of certain causes of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.  The iFuse Implant was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and has been the subject of more than 50 peer-reviewed publications, including two Level 1 randomized controlled trials (www.si-bone.com/results), published since its introduction to the market in 2009.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain.  Patients with certain types of sacroiliac joint dysfunction experience pain that can be debilitating.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

One or more of the individuals referred to herein are investigators participating in clinical research sponsored by SI-BONE, paid consultants of SI-BONE and/or SI-BONE stockholders.

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc.  ©2018 SI-BONE, Inc. All Rights Reserved. 10143.040918

  1. Bernard TN, Kirkaldy-Willis WH. Recognizing Specific Characteristics of Nonspecific Low Back Pain. Clin Orthop Relat Res. 1987;217:266–80.
  2. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
  3. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
  4. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
  5. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.
  6. Fortin JD, Falco FJ. The Fortin finger test: an indicator of sacroiliac pain. Am J Orthop (Belle Mead NJ). 1997;26(7):477–480.

 

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

SI-BONE, Inc. Announces Publication of 3-Year Long-term Prospective Outcomes Including Randomized Controlled Trial Data Post SI Joint Fusion with Triangular iFuse Implant System®

SAN JOSE, Calif.April 9, 2018 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the minimally invasive surgical (MIS) treatment of the sacroiliac (SI) joint with the iFuse Implant System® (“iFuse”) announced the publication of results from a long-term outcomes study called LOIS (Long Term Outcomes from INSITE and SIFI).  The publication, titled Long-term prospective outcomes after minimally invasive trans-iliac sacroiliac joint fusion using triangular titanium implants1 reports 3-year results of a subset of patients who participated in INSITE (Investigation of Sacroiliac Fusion Treatment)2, a U.S. randomized controlled trial and SIFI (Sacroiliac Joint Fusion with iFuse Implant System)3, a U.S. prospective multicenter trial.  The 3-year results from LOIS demonstrated that improvements in pain, function and quality of life achieved at 2-years were sustained at 3-years and patient satisfaction remained high for patients treated with the iFuse Implant, available in the US since 2009.  There were no reported adverse events related to the study device or procedure in the extended follow-up period.

The 3-year LOIS study results include 103 subjects at 12 medical centers with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption who were evaluated in study clinics at study start and at 3, 4 and 5 years follow-up.  3-year follow-up was 93%. Mean preoperative SI joint pain was 81.5 (0 to 100 VAS) and decreased to 26.2 at 3-years, a 55-point improvement (Figure 1).  Mean preoperative Oswestry Disability Index (ODI) was 56.3 and decreased to 28.2 at 3-years, a 28.1-point improvement (Figure 2).

“The 3-year LOIS results show that clinically significant improvements from both INSITE and SIFI patients were sustained at 3-years demonstrating that the benefits of SI joint fusion with iFuse are durable,” said Emily Darr, MD, Assistant Professor, Orthopaedic Surgery, Medical University of South Carolina College of Medicine and lead author on the publication.  “Furthermore, the diagnosis of SI joint mediated pain has been described as challenging, but our results suggest that SI joint dysfunction can be reliably diagnosed through appropriate history, physical exam and response to diagnostic block and can be effectively treated.”

“Based on the 56 peer-reviewed publications on iFuse,  fourteen (14) commercial payers have established positive coverage policies for MIS SI joint fusion exclusively for the triangular iFuse Implant System from SI-BONE and no other SI joint fusion implants are covered by those payers,” stated Daniel Cher, MD, Vice President of Clinical Affairs at SI-BONE.

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain4-7, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.8  SI joint dysfunction is often misdiagnosed and the resulting pain can be incorrectly attributed to other causes.  SI joint dysfunction can be identified when a patient points to the source of their pain directly over the posterior superior iliac spine (PSIS), known as the Fortin Finger Test9, combined with a number of positive provocative maneuvers that stress the SI joint and elicit pain, followed by image-guided diagnostic injections to confirm the diagnosis.  The SI joint is the largest of the eight major joints in the human body and the last to have a proven surgical treatment.  The iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of certain causes of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.  The iFuse Implant was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications, including two Level 1 randomized controlled trials (www.si-bone.com/results).

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain.  Patients with certain types of sacroiliac joint dysfunction experience pain that can be debilitating.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2018 SI-BONE, Inc. All Rights Reserved. 10133.032818

  1. Darr E, Meyer SC, Whang PG, Kovalsky D, Frank C, Lockstadt H, Limoni R, Redmond A, Ploska P, Oh MY, Cher D, Chowdhary A. Long-term Prospective Outcomes After Minimally Invasive Trans-Iliac Sacroiliac Joint Fusion Using Triangular Titanium Implants. Medical Devices: Evidence and Research. 2018:11;113-121. doi: 10.2147/MDER.S160989.
  2. Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10:Article 28. doi: 10.14444/3028.
  3. Duhon BS, Bitan F, Lockstadt H, Kovalsky DA, Cher DJ, Hillen T, on behalf of the SIFI Study Group. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-year Follow-up from a Prospective Multicenter Trial. Int J Spine Surg. 2016;10:Article 13. doi: 10.14444/3013.
  4. Bernard TN, Kirkaldy-Willis WH. Recognizing Specific Characteristics of Nonspecific Low Back Pain. Clin Orthop Relat Res. 1987;217:266–80.
  5. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
  6. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
  7. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
  8. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.
  9. Fortin JD, Falco FJ. The Fortin finger test: an indicator of sacroiliac pain. Am J Orthop (Belle Mead NJ). 1997;26(7):477–480.

 

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

InVivo Therapeutics Provides Business Update

April 09, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (Nasdaq:NVIV) today provided a general business update. The company is announcing a 1-for-25 reverse stock split of its common stock and a proportionate reduction in its authorized common stock. The company anticipates the reverse stock split will become effective at 5:00 p.m. Eastern Time on April 16, 2018, and shares of InVivo Therapeutics common stock will trade on a post-split basis under the Company’s existing trading symbol, “NVIV,” at the market open on April 17, 2018. The new CUSIP number for the Company’s common stock following the reverse stock split will be 46186M 407.

At the effective time of the reverse stock split, every 25 shares of InVivo Therapeutics common stock will be combined into 1 share of InVivo Therapeutics common stock. In connection with the reverse stock split, the authorized shares will be reduced from 100 million shares to four million shares. The reverse stock split is anticipated to reduce the company’s issued and outstanding shares of common stock from approximately 38.1 million to approximately 1.52 million. In addition, proportionate adjustments will be made to the exercise prices of the company’s outstanding stock options and warrants and to the number of shares issued and issuable under the company’s existing stock incentive plans.

The company also announced that it is in the process of finalizing a lease assignment, expected to result in lease-related savings of approximately $3M through 2019. In addition to the lease assignment, InVivo is undertaking other key initiatives to align its core competencies and business strategy in the most cost-efficient manner. Based on these initiatives, InVivo projects its average cash burn over the last three quarters of 2018 to be approximately $1M per month, compared to an average cash burn of approximately $1.5M per month during the last three quarters of 2017 and the first quarter of 2018.

“InVivo remains committed to executing on its near-term goals while building momentum to create shareholder value. Cost-saving initiatives, including the proposed assignment of our lease, will allow us to continue to chart our new path forward,” said Richard Toselli, M.D., President and Chief Executive Officer of InVivo Therapeutics. “In light of this strategy and after careful consideration, we further determined that a reverse stock split will best allow us to achieve future financing goals on favorable terms for the company and its shareholders. We have received the support of our Board of Directors in taking these actions, and we look forward to providing further updates as we explore financing options.”

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In January 2018, the company announced updated clinical evidence, including improvements in patients with acute spinal cord injury (SCI), from its INSPIRE study of the Neuro-Spinal Scaffold™. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect” and similar expressions, and include statements regarding the company’s planned reverse stock split and planned cost savings initiatives, including the proposed assignment of its lease. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to: the company’s ability to effect the 1-for-25 reverse stock split and the administrative process related thereto, to successfully identify financing alternatives and raise the capital necessary to undertake the second pivotal trial, to successfully decrease costs and spend and to successfully open additional clinical sites for enrollment and to enroll additional patients if such trial is initiated; the timing of the Institutional Review Board process; the company’s ability to obtain FDA approval to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2017 and its other filings with the SEC, including the company’s quarterly reports on Form 10-Q and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

SpineGuard Reports Q1 2018 Revenue

April 05, 2018

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets instruments designed to secure the placement of surgical implants by bringing real-time digital technology into the operating room, reported today its first-quarter 2018 revenue of €1.95m decreasing 7.9% in constant currency (-2.9% in the USA) and of €1.8m at actual exchange rate.

Stéphane Bette, CEO and co-founder of SpineGuard, said: “The sales result in the first quarter was impacted by a base effect as well as an unfavorable dollar-euro exchange rate. This trimester also includes the preparation work for deploying the “Smart Screw” embedded with DSG™ sensing technology in the USA, where we signed with Zavation an additional distribution agreement allowing us to directly serve our customers and contribute from now on to significantly increase our revenue per surgery. Our teams are mobilized to reach our goal of operational profitability by year-end thanks to expense control discipline as well as geographic focus on the USA, France and China where we just delivered a second order.

Global revenue in the first quarter of 2018 was €1,769k vs. €2,169k in Q1 2017 strongly impacted by the decrease of the US Dollar relative to the Euro, i.e. -18.4%. The decrease was 7.9% cc.

SpineGuard sold 2,351 DSG™ units in the first quarter of 2018 vs. 2,397 units in Q1 2017. 1,306 units (56%) were sold in the USA where the revenue decreased 2.9% in constant currency (-15.9% at actual exchange rate) at USD 1,846k vs. USD 1,901k.

Recent events:

February 2018

SpineGuard S.A (Paris) passed successfully the three-year cycle CE mark
renewal audit by the TÜV SÜD.

March 2018

“SmartScrew Technology Reduces Radiation Exposure and OR Time in MIS
Lumbar Surgery” Article published in Becker’s Spine Review.

Here.

March 2018

SpineGuard S.A (Paris) underwent an inspection by the U.S. Food and Drug
Administration without any inspectional observations.

March 2018

Publication of a German study recognizing PediGuard as a safety tool for
securing cervical screw placement in the peer-reviewed scientific journal
European Spine Journal. Find the abstract Here.

Next financial press release: 2018 Half-year revenue: July 11, 2018

About SpineGuard®
Founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 60,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

Contacts

SpineGuard
Stéphane Bette, Tel: +33 (0)1 45 18 45 19
Chief Executive Officer
s.bette@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Mathilde Bohin / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.eu

Esaote Introduces new extremity MRI systems, O-scan Premium and O-scan Light at the AAOE 2018 Annual conference

FISHERS, Ind.April 6, 2018 /PRNewswire/ — Responding to the market need for high performance extremity MRI systems, Esaote launches the new O-scan Premium* extremity MRI system and its value version, the O-scan Light*. The O-scan Premium and the O-scan Light will be shown at the American Association of Orthopaedic Executives (AAOE), Hyatt Regency, Orlando, Booth #219.

Esaote is a world leader in dedicated MRI with over 30 years of innovation in the field of musculoskeletal MRI, producing cost-effective systems that provide clinicians with outstanding image quality, flexibility, ease of use, and patient comfort. The O-scan Premium is the extremity MRI of choice for sites that require high throughput, improved workflow and advanced applications. The O-scan Light is the perfect choice for high quality MRI with an emphasis on overall value and economic.

“The introduction of the expanded range of O-scan Extremity MRI Systems provides more choices for Healthcare Providers and Hospitals to provide high quality imaging directly to their patients,” states Glenn Davis, President and General Manager, of Esaote North America, Inc. “The O-scan offers a complete range of high quality imaging capabilities for extremities whilst providing an optimal patient experience, thanks to its unique ergonomics and open design.”

Powered by the eXP technology, the O-scan Premium offers exceptional image quality, patient throughput, optimized workflow and faster scan times in both private practice, clinics and hospital setting, specifically targeted to Orthopedic Surgeons, Radiologists, and Rheumatologists. The O-scan Light represents an affordable choice without compromise, specially designed to meet the image quality, easy workflow and patient comfort expectations required for Podiatry private practices. With unique image optimization and advanced diagnostic tools, and Italian engineering and design, clinicians can quickly acquire exceptional images for increased diagnostic confidence.

About Esaote: With a consolidated turnover of EUR 270 million in 2016, the Esaote Group is a leader in the biomedical equipment sector, in particular the areas of ultrasound, dedicated MRI and software for managing the diagnostic process. The Group currently employs 1,200 people. With its own production and research units in Italy and the Netherlands, Esaote is recognized as one of the top 10 diagnostic imaging companies in the world.

Esaote will be exhibiting the O-scan Premium and O-scan Light at AAOE 2018 Annual Conference.

Esaote@AAOE 2018:  Esaote will be exhibiting at AAOE 2018- American Association of Orthopaedic Executives 2018, April 14th – April 17th, 2018.

LOCATION:

Hyatt Regency Orlando, Orlando, FL – AAOE 2018 – Booth #219

* Technology and features are system/configuration dependent. Specifications are subject to change without notice. Information might refer to products or modalities not yet approved in all countries. For further details, please contact your Esaote sales representative.

Contact lrojas@esaoteusa.com

SOURCE Esaote North America

Related Links

https://www.esaoteusa.com