+44 (0)203 011 5574 info@orthocg.com
OrthoGrid Systems to Launch Intraoperative PhantomMSK™ Application for Hip Preservation Procedures

OrthoGrid Systems to Launch Intraoperative PhantomMSK™ Application for Hip Preservation Procedures

New fluoroscopic alignment system is engineered for clinical applications in peri-acetabular osteotomy and femoral acetabular impingement

SALT LAKE CITY, UTAH, February 12, 2019 – OrthoGrid Systems, Inc., a leading innovator in surgical imaging, workflow efficiency and decision-making support in orthopedic surgery, today announced that its new PhantomMSK™ Hip Preservation System, with novel new applications for peri-acetabular osteotomy (PAO) procedure and treatment of femoral acetabular impingement (FAI), will be unveiled at the 2019 annual meeting of American Academy of Orthopaedic Surgeons in Las Vegas, NV. OrthoGrid Systems will be in Hall A, booth #625.

“Developmental dysplasia of the hip (DDH) is a relatively common condition that can lead to early onset osteoarthritis, pain, and limited mobility,” explained Richard Boddington, CEO of OrthoGrid Systems. “Because DDH can be difficult to treat and can also become symptomatic early in life due to bony impingement and profound cartilage loss, there is a tremendous need for better solutions. OrthoGrid’s new PhantomMSK™ Hip Preservation applications are exceptional because they seamlessly integrate into the standard workflow, enhance procedural decision making, and confirm preoperative surgical plans intraoperatively during these complex surgeries”

OrthoGrid’s PhantomMSK™ System is a digital platform for orthopedics that also includes patented solutions for total hip arthroplasty and other in-process applications. In conjunction with OrthoGrid’s HipGrid® and HipGrid® NINE product lines, the PhantomMSK™ offers a clinically relevant, cost-effective, and completely mobile solution that can be installed in either ambulatory surgical centers or hospitals.

“Peri-acetabular osteotomy can be a technically demanding procedure, and physicians rely heavily on fluoroscopic imaging that is often marred by fluoroscopic distortion,” noted renowned Salt Lake City-based orthopedic surgeon, Christopher Peters, MD. “OrthoGrid’s PhantomMSK™ System directly addresses the distortion in a manner that is simple and that can contribute to a tremendous difference in the final outcome.”

For more information about OrthoGrid System’s portfolio of orthopedic solutions, please visit our website at http://www.orthogrid.com.

About OrthoGrid Systems, Inc. 
OrthoGrid Systems is a rapidly expanding global leader in intraoperative imaging technologies targeting component and anatomic alignment, imaging efficiency, optimized visualization and decision-making support for orthopedic surgery. OrthoGrid specializes on leveraging the latest innovation in technology to create practical and efficient solutions available or in development for hip arthroplasty, hip preservation, trauma and other common procedures performed over 10 million times per year globally. Learn more about OrthoGrid and our products by visiting our website at http://www.orthogrid.com.

Source: OrthoGrid Systems, Inc. PrNewswire Feb 12, 2019
Media Contact: Edouard Saget, President 
Email: info@orthogrid.com 
Phone: 801-703-5866

SpinalCyte Announces New Canadian Patent

SpinalCyte Announces New Canadian Patent

HOUSTON, Feb. 11, 2019 /PRNewswire/ — SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc using Human Dermal Fibroblasts (HDFs), today announced the issuance of a new patent in Canada. The patent adds to the company’s intellectual property portfolio with 37 U.S. and international patents issued with 100+ patents pending focused on fibroblast technologies. The company received IND clearance from the FDA in November to continue clinical trials into its lead fibroblast cell therapy product, CybroCell, in the treatment of degenerative disc disease.

“SpinalCyte is at the forefront of fibroblast cell therapy technologies,” said Pete O’Heeron, Chief Executive Officer of SpinalCyte. “We have now been issued 37 patents for our core technologies and we intend to continue to strategically broaden and leverage our intellectually property position.”

The technologies described in Canadian patent No. 2,925,550, “Methods and Compositions For Repair Of Cartilage Using An In Vivo Bioreactor,” are related to subjecting fibroblast cells to specific environments in order to differentiate them into chondrocytes for use in spinal discs and other joints.

About Degenerative Disc Disease

Degenerative disc disease (DDD) is a condition in which a patient’s spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3 million procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion. Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together. It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration.

About CybroCell

CybroCell is the first off-the-shelf allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease. SpinalCyte’s Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated after 12 months, patients injected with CybroCell had sustained improvement in pain relief and increased back mobility.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC, is a regenerative medicine company developing an innovative solution for spinal replacement using human dermal fibroblasts. Currently, SpinalCyte holds 37 U.S. and international issued patents and has filed for an additional 100+ patents pending and issued across a variety of clinical pathways, including disc degeneration, cancer, diabetes, liver failure and heart failure. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contact: 
David Schull or Ned Berkowitz
Russo Partners LLC
858-717-2310
646-942-5629
david.schull@russopartnersllc.com
ned.berkowitz@russopartnersllc.com

Clinical Contact: 
info@spinalcyte.com

SOURCE SpinalCyte, LLC, PRNewswire Feb 11, 2019

Related Links

http://www.spinalcyte.com
Largest Ever Clinical Trial in Hip Fracture Fixation Completes One-Year Follow-Up in 1000th Patient

Largest Ever Clinical Trial in Hip Fracture Fixation Completes One-Year Follow-Up in 1000th Patient

DUBLIN, January 23, 2019 /PRNewswire/ —

X-BOLT® Revolutionary Hip Fracture Device Granted FDA 510k Approval

X-Bolt Orthopaedics, a leading medical device company, today announced the 1000th patient has completed one-year of follow-up in the (n= 1,140 patients) multi-centre randomised controlled trial comparing extracapsular hip fracture fixation devices, known as World Hip Trauma Evaluation 4 (WHITE4), conducted by Oxford University and supported by NIHR Oxford Biomedical Research Centre. The Company’s X-BOLT® innovative hip fracture device was also granted FDA 510k approval for marketing in the United States in Q4 2018.

Addressing the growing socio-economic problems of treating hip fractures in frail elderly patients, X-BOLT® is designed to revolutionise current surgical treatment and significantly reduce re-operation rates. Most clinical complications occur with anchorage in the osteoporotic bone and X-BOLT® offers an innovative mechanism that uses wings that expand in situ to offer a rotationally stronger and more secure femoral bone anchorage than traditional screw fixation. A stronger leg to stand on post-surgery allows for faster, fuller and more confident mobilisation of the patient.

Recruitment for WHITE4 commenced in June 2016 and involved 10 centres in UK, collaborating with the Orthopaedic Trauma Society (GB&I), including Oxford, Northumbria, Leicester, Newcastle, South Tees, Frimley Park, Wexham, Coventry, Bristol and Portsmouth. Results are expected to be available in June 2019. Patients were randomised at the time of surgery to receive either a gold standard sliding hip screw (SHS) device or X-BOLT®. Follow-up for all patients occurred at baseline, 4 months and one year following surgery.

Outcome measurements in WHITE4 include the EuroQol 5 Dimension Score (EQ-5D-5L), a validated measure of health-related quality of life, as well as patient mortality, residential status, revision surgery and radiographic measures. This study is a fully powered superiority study that may definitively show the X-BOLT® clinically to be the new gold standard femoral head fixation in hip fracture fixation.

A 100-patient randomised pilot study published in 2016, known as ‘WHITE1’ at the University of Warwick showed a zero (0%) re-operation rate with the X-BOLT® device, versus a 6% reoperation rate with the traditional sliding hip screw (SHS) in unstable intertrochanteric hip fractures. Full results of WHITE1 are published in the Bone Joint Journal 2016; 98-B: 686-9.

Professor Xavier Griffin, the Chief Investigator of the WHITE 4 trial at Oxford Trauma, commented on the trial, “This is the largest randomised clinical trial in the field of hip fracture fixation and we are delighted to have hit this significant milestone. X-Bolt should be congratulated as an exemplar company for their commitment to working with us using the IDEAL framework in delivering this novel device to market. We look forward to communicating the full results of the trial in June 2019.”

Dr. Brian Thornes, CEO of X-BOLT Orthopaedics said, “Hip fractures in the very elderly are a growing unmet medical need with current surgical procedures resulting in poor outcomes that often result in a loss of mobility and independence in vulnerable group of patients. Hip fracture fixation has lacked any significant innovation since Sir John Charnley patented the sliding hip screw in 1955. We believe that the X-BOLT® device has the potential to transform fixation in patients suffering from osteoporosis and hip fractures, providing a significant improvement in mobility and quality of life.”

Approximately 1.6 million hip fractures occur worldwide each year and due to an aging population, it is expected this number could reach 6 million by 2050. Each hip fracture episode costs approximately $40,000 (£30,000) in health and social costs. 70% of hip fractures occur in women with a median age of 81yrs. Loss of mobility and independence among hip fracture survivors is profound; less than 50% regaining their previous function and 33% being totally dependent or in a nursing home a year later. Reoperations occur in 6% of patients, resulting in additional costs of approximately $50,000 (£35,000). Reducing the re-operation rate provides a significant opportunity for hospitals and governments to greatly reduce 30-day readmissions and overall healthcare costs, notwithstanding the benefits to patients by improving their quality of life.

The X-BOLT® hip fracture nailing and plating systems were also recently granted FDA 510k approval in Q4 2018, having undergone rigorous mechanical and biocompatibility testing, along with interactions with the US Food and Drug Administration since 2013. This FDA approval now permits the marketing and commercialisation of the X-BOLT® in the United States.

About X-BOLT Orthopaedics

X-BOLT® Orthopaedics is an Irish medical device company, that has designed and developed a highly innovative and unique range of hip nailing and plating solutions suitable for all hip fractures that require fixation. The X-BOLT® (“Expanding Bolt”) hip fixation system significantly improves anchorage in osteoporotic bone and reduces the requirement for costly repeat surgeries (due to significantly lower reoperation rates), as well as allowing greater confidence to mobile fully weight bearing post operation.
X-BOLT® has strong scientific evidence via extensive clinical trials and has received European CE Mark from the British Standards Institute (BSI) and FDA 510k approval for marketing in the US.

Founded and led by Dr. Brian Thornes, an experienced orthopaedic surgeon with extensive development experience having previously invented, developed and licensed the ankle syndesmosis “TightRope” device to Arthrex, Inc (Naples, FL) in 2003. To date, over 300,000 Tightropes have been implanted worldwide, with many top football and rugby professionals amongst its recipients. Recently published multicentre clinical trials have shown that the Tightrope has set the new gold standard for ankle syndesmosis injuries.

The National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC)

NIHR Oxford Biomedical Research Centre (BRC) is based at the Oxford University Hospitals  NHS Foundation Trust and run in partnership with the University of Oxford. The NIHR is the nation’s largest funder of health and care research. The NIHR:

Funds, supports and delivers high quality research that benefits the NHS, public health and social care
Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
Partners with other public funders, charities and industry to maximise the value of research to patients and the economy
The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR commissions applied health research to benefit the poorest people in low- and middle-income countries, using Official Development Assistance funding.

The Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS)

NDORMS is a multi-disciplinary department focusing on discovering the causes of musculoskeletal and inflammatory conditions to deliver excellent and innovative care that improves people’s quality of life. The largest European academic department in its field, NDORMS is part of the Medical Sciences Division of the University of Oxford, and is a rapidly growing community of more than 400 orthopaedic surgeons, rheumatologists and scientists all working in the field of musculoskeletal disorders.

The research work of the department takes place in several locations across the Nuffield Orthopaedic Centre, namely the Botnar Research Centre, and the Kennedy Institute of Rheumatology. The co-location with NHS services puts the department in an excellent position with basic researchers working alongside clinicians. This substantially improves research capacity, improving access for researchers to patients, and facilitating the interaction between clinicians and scientists that is essential for successful medical research. www.ndorms.ox.ac.uk

Contact information:
X-BOLT
Brian Thornes, CEO
brian.thornes@x-bolt.com

Katja Stout, Scius Communications
katja@sciuscommunications.com

SOURCE X-BOLT Orthopaedics, PRNewswire, 23, Jan 2019

Generex Biotechnology Announces Acquisition of Surgical Device Manufacturer

Generex Biotechnology Announces Acquisition of Surgical Device Manufacturer

Pantheon Medical manufactures a line of FDA cleared products used in orthopedic surgeries including screws, plates, implants, and anchors

MIRAMAR, Fla.–(BUSINESS WIRE)–Generex Biotechnology Corporation (OTCQB:GNBT) is pleased to announce that the company has entered into a letter of intent (LOI) to acquire Pantheon Medical – Foot & Ankle, a manufacturer of specialty orthopedic surgery products and tools. Under the terms of the deal, Generex will acquire all of the assets of Pantheon Medical including business operations, accounts receivable and inventory, contracts, and an FDA letter related to balanced plating system, on a debt free basis, for One Million Four Hundred Thousand Dollars ($1,400,000) worth of Generex (GNBT) stock, plus additional cash and stock consideration upon achieving certain sales and profit goals.

Pantheon Medical – Foot & Ankle is a multi-million dollar company that began operations in 2014 with a physician friendly, “all-in-one,” integrated kit that includes plates, screws, and tools required for orthopedic surgeons and podiatrists conducting foot and ankle surgeries. Over the next three years, the Company will be developing and submitting several new product lines to the FDA which will include cannulated surgical screws and surgical staples, as well as a proprietary Hammertoe System.

Travis H. Bird, CEO of Pantheon Medical, commented on the deal, “Partnering with Generex will enable us to expedite Pantheon’s ability to build a manufacturing company with proprietary product lines that offer convenience and cost effectiveness to physicians. We are already seeing significant uptake in the marketplace with our ‘one stop shop’ approach to orthopedic surgery, and the new product lines will expand our market reach.”

“The acquisition of Pantheon expands the commercial product portfolio of Generex into the surgical field, adding revenues and profits with their current product line and significant upside opportunities for new FDA-approved product introductions over the next several years,” stated Joe Moscato, CEO of Generex. “Our MSO partners, many of whom are orthopedic surgeons and podiatrists, will immediately benefit from Pantheon’s Foot & Ankle surgery kit. The acquisition demonstrates Generex’s commitment to providing end-to-end solutions that enhance physician’s practice and improve outcomes for patients. We are in the process of completing the due diligence on the Pantheon acquisition, with plans to close the transaction in the coming weeks.”

About Generex Biotechnology Corp.

Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

In addition to advancing a legacy portfolio of immune-oncology assets, medical devices, and diagnostics, the Company is focused on an acquisition strategy of strategic businesses that complement existing assets and provide immediate sources of revenue and working capital. Recent acquisitions include a management services organization, a network of pharmacies, clinical laboratory, and medical device companies with new and approved products.

Our newly formed, wholly-owned subsidiary, NuGenerex Distribution Solutions (NDS), integrates our MSO network with a pharmacy network, clinical diagnostic lab, durable medical equipment company (DME-IQ) and dedicated call center.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as “expects,” “plan,” “believes,” “will,” “achieve,” “anticipate,” “would,” “should,” “subject to” or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Contacts
Generex Biotechnology Corporation

Joseph Moscato
646-599-6222

Todd Falls
800-391-6755 Extension 222

investor@generex.com

SOURCE: BusinessWire, Jan 09, 2019

CartiHeal’s Agili-C™ Implant Promotes the Regenerative Capacity of Articular Cartilage Defects in Human Cadaveric Ex-vivo Model

CartiHeal’s Agili-C™ Implant Promotes the Regenerative Capacity of Articular Cartilage Defects in Human Cadaveric Ex-vivo Model

KFAR SABA, IsraelNovember 7, 2018 /PRNewswire/ —

CartiHeal, developer of Agili-C™, a proprietary implant for the treatment of joint surface lesions, announced today the publication of a study demonstrating that the Agili-C™ implant promotes the regenerative capacity of articular cartilage defects in human cadaveric ex-vivo model. The study, published in KSSTA Journal – Knee Surgery, Sports Traumatology, Arthroscopy (01 November 2018, PP 1-12), was conducted at Rush University in Chicago by Prof. Susan Chubinskaya.

     (Logo: https://mma.prnewswire.com/media/451231/CartiHeal_Logo.jpg )

The goal of the study was to investigate the ex-vivo Mechanism Of Action of the Agili-C™ implant in the repair of full-thickness cartilage defects. In particular, it was intended to validate whether the Agili-C™ implant has the potential to stimulate cartilage in-growth through chondrocyte migration into the 3D interconnected porous structure of the scaffold, along with maintaining their viability and phenotype and the deposition of hyaline cartilage matrix.

In the study, human articular cartilage cadaveric knee and ankle specimens were collected within 24 hours from death from 14 donors, male and female. To model a chondral defect, donut-shaped cartilage explants were prepared from each tissue specimen. Cartilage explants with or without the Agili-C™ implant inside were cultured for 60 days.

The results of the study confirmed the ability of chondrocytes to migrate outside of the cadaveric cartilage explant tissue and into the porous structure of the Agili-C™ scaffold and fill its entire volume with newly formed extracellular matrix (ECM) enriched in hyaline cartilage components, such as collagen type II and aggrecan, and lacking collagen type I.

In addition, the study demonstrated the formation of a layer populated by progenitor-like cells on the articular surface of the implant. These cells were able to produce a thin layer that covered the surface of the newly formed extracellular matrix, similar to a lamina.

In the absence of a scaffold, chondrocytes did not migrate far from the tissue with probably some degree of hypertrophy.

In conclusion, the analysis of samples taken from knee and ankle joints of human donors confirmed that the Agili-C™ implant induces deposition of new extracellular matrix with similar characteristics to the native hyaline cartilage inside the entire volume of the scaffold.

About CartiHeal 

CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

In the United States, the Agili-C™ implant is not available for sale – it is an investigational device limited for use in the IDE study.  

Contact:
info@cartiheal.com
http://www.cartiheal.com  

SOURCE CartiHeal, PRNewswire, Nov 7, 2018 – http://www.prnewswire.co.uk/news-releases/cartiheals-agili-c-implant-promotes-the-regenerative-capacity-of-articular-cartilage-defects-in-human-699910941.html