Category: Knee deformation

Carlsbad, California, October 23, 2023 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSX VENTURE: ASG) (OTCQB: ASAPF) is pleased to announce that it has completed a non-brokered private placement of units (“Units”) at gross proceeds of approximately CDN$1.9 million (the “Offering”).

As a result of the Offering, the Company issued 6,445,939 Units at a price of CDN$0.30 per Unit. Each Unit consists of one common share of the Company and one warrant to purchase common shares of the Company. Each whole warrant is exercisable at a price of CDN$0.50 per common share for a period of 24 months from the date of issuance. In connection with the Offering, the Company paid finders’ fees in the aggregate amount of CDN$50,700. PowerOne Capital Markets Limited acted as finder in connection with a portion of the Offering.

The Company intends to use the proceeds from the Offering to finance increased working capital resulting from expected growth in sales of several of its new products, including SiLO TFX and Dexa/Apollo, and from ZIP’s continued growth as Aurora adds new direct sales staff.

The securities issued under the Offering will be subject to a four-month hold period in accordance with applicable securities laws. The Offering is subject to final approval by the TSX Venture Exchange.

Certain directors of the Company (collectively the “Insiders”) participated in the Offering and as such the Offering may constitute a related party transaction under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”) , but is otherwise exempt from the formal minority interest valuation and approval requirements of MI 61-101 under sections 5.5(a) and 5.7(1)(a) of MI 61-101 with respect to such Insider participation in the Offer . No special committee has been established in connection with the Offering or the Insiders’ participation in the Offering, and no material contrary position has been expressed or abstained from by any director of the Company in connection therewith. Further details will be included in a material changes report to be submitted by the Company in connection with the completion of the Offering. The Company filed the material change report no more than 21 days prior to the initial closing date of the Offering as the terms of the Offering and the total amount to be invested by the Insiders were only settled shortly before the closing of the Offering. and the Company wished to complete the Offering on an accelerated basis for sound business reasons.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “US Securities Act”) or any state securities laws, and may not be offered or sold within the United States or to US persons, unless registered under the United States Securities Act and applicable state securities laws or an exemption from such registration is available.

About Aurora Spine

Aurora Spine focuses on bringing new solutions to the spine implant market through a range of innovative, minimally invasive, regenerative spine implant technologies. Additional information can be found at www.aurora-spine.com or www.aurorapaincare.com.

Forward-Looking Statements

This press release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond Aurora Spine’s control, including, without limitation, those set forth under “Risk factors” And “Cautionary Note Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this press release includes information regarding the Offering, the completion of the Offering and the approval of the Offering by the TSX Venture Exchange. Aurora Spine cautions investors in the securities of Aurora Spine of important factors that could cause Aurora Spine’s actual results to differ materially from those projected in the forward-looking statements contained in this press release. Any statements that express or imply expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties that could cause actual results or outcomes. to differ unilaterally from the statements expressed in such forward-looking statements. There can be no assurance that the expectations set forth herein will prove to be correct and, accordingly, potential investors should not place undue reliance on these forward-looking statements. These statements speak only as of the date of this press release.

For more information please contact:

Aurora Spine Corporation

Trent Northcutt
president and director
(760) 424-2004

Chad Clouse
Finance Director
(760) 424-2004

www.aurora-spine.com

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

FREMONT, Calif., Oct. 23, 2023 /PRNewswire/ — THINK Surgical, Inc., an innovator in orthopedic surgical robots, today announced that its TMINI™ Miniature Robotic System has received special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with implants from three additional implant manufacturers.

The TMINI system includes a wireless robotic handpiece that helps surgeons perform total knee replacements and received its first 510(k) clearance from the U.S. FDA in April 2023 for use with an implant from a single implant manufacturer.

THINK Surgical is committed to an open implant library. The addition of the Classic^® Knee System (Total Joint Orthopedics Inc.), Balanced Knee System (BKS^®) and BKS TriMax^® Knee System (Ortho Development Corporation) and U2™ Knee (United Orthopedic Corporation) to THINK Surgical’s Implant Data Hub (ID-HUB), a proprietary database of implant modules for use with the TMINI System, opens access and choice to surgeons.

“We are excited to expand the number of implant modules supported by the TMINI system, giving more customers and patients access to robot-assisted technology for knee replacement.” said Stuart Simpson, president and CEO of THINK Surgical. “We are currently working on adding more implant modules to the TMINI system to continue our mission of an open implant library.”

About THINK Surgical, Inc.

THINK Surgical, Inc. is a privately held, US-based technology innovator that develops and commercializes orthopedic robots. THINK Surgical robots are open platforms that support implant brands from multiple manufacturers, allowing the surgeon to determine the implant choice.

THINK Surgical actively works with healthcare professionals around the world to refine our orthopedic products to improve the lives of people suffering from advanced joint conditions with accurate, precise and intelligent technology. Refer to the TMINI Miniature Robotic System Instructions for Use for a complete list of indications, contraindications, warnings and precautions. For additional product information, please visit www.thinksurgical.com.

THINK Surgical and TMINI are trademarks of THINK Surgical, Inc.

Media contacts:

THINK surgical
Nick Margree
nmargree@thinksurgical.com

SOURCE THINK Surgical, Inc.

Expands Xtant’s manufacturing capabilities and capacity to drive growth

BELGRADE, Mont., Oct. 23, 2023 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American: XTNT), a global medical technology company focused on surgical solutions for the treatment of spinal conditions, today announced that it has acquired the nanoOss manufacturing operations of RTI Surgical, Inc., a leading CDMO in the field of regenerative medicine.

Under the terms of the purchase agreement, Xtant acquired certain assets, including equipment and inventory, used in RTI’s synthetic bone graft business, and assumed from RTI the lease for the nanOss manufacturing facility in Greenville, NC. The purchase price for the assets was $2 million in cash plus contingent payments based on future sales of next-generation nanOss products. Xtant previously acquired nanOss’ distribution rights and nanOss intellectual property with the acquisition of Surgalign’s assets related to its biologics and spinal fixation businesses in August 2023.

“nanOss is an important part of our overall orthobiology offering, and having full control of this product line will allow us to continue the process of reinvigorating and growing it,” said Sean Browne, Chief Executive Officer of Xtant Medical. “This deal meets every element of our acquisition criteria and positions us to improve our production capabilities, capacity and cash flows.”

About Xtant Medical Holdings, Inc.

Xtant Medical Holdings, Inc. (www.xtantmedical.com) is a global medical technology company focused on the design, development and commercialization of a comprehensive portfolio of orthobiology spinal products and implant systems to facilitate spinal fusion in complex spine, deformity and degenerative procedures. ease . Xtant’s people are dedicated and talented and work with the highest integrity to serve our customers.

The symbols ™ and ® indicate trademarks and registered trademarks of Xtant Medical Holdings, Inc. or its affiliates, registered as indicated in the United States and other countries. All other trademarks and trade names referred to in this press release are the property of their respective owners.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are predictive in nature, that depend on or refer to future events or circumstances, or that contain words such as “intends” , “expects,” “anticipates,” “plans,” “believes,” “estimates,” “continues,” “future,” “will,” “potential,” similar expressions or the negative thereof, and the use of future dates. Forward-looking statements in this press release include the company’s expectations regarding the revival and growth of the nanoOss product line and the improvement of manufacturing capabilities, capacity and cash flows. The Company cautions that its forward-looking statements, by their nature, involve risks and uncertainties, and actual results may differ materially depending on a number of important factors, including, among others: the Company’s inability to achieve expected revenues and any costs or revenues expected from the RTI transaction or delays in its realization; delays and challenges in integrating the nanoOss product line and manufacturing operations with the Company’s operations; the company’s future operating results and financial performance; its ability to increase or maintain revenues; risks associated with the acquisition of nanoss’ manufacturing activities and prior acquisitions; possible future impairments of long-lived assets and goodwill and write-downs of excess inventories if revenues decline; the ability to remain competitive; the ability to innovate, develop and introduce new products; the ability to attract and retain new and existing independent distributors and agents and qualified personnel and the Company’s dependence on key independent agents for a significant portion of its revenue; the effect of COVID-19, labor and hospital staff shortages on the Company’s business, results of operations and financial condition, particularly as they impact key markets; the company’s ability to successfully implement its future growth initiatives and the risks associated therewith; the effect of inflation, higher interest rates and other recessionary factors and supply chain disruptions; the effect of changes in product sales mix on the company’s financial results; government and third party coverage and reimbursement for company products; the ability to obtain and maintain regulatory approvals and comply with government regulations; the effects of product liability claims and other legal proceedings to which the Company may be subject; the effect of product recalls and defects; the ability to obtain and protect the Company’s intellectual property and proprietary rights and operate without violating the rights of others; the ability to service the company’s debt, comply with debt covenants and access additional debt; the ability to obtain additional financing on favorable terms or at all; and other factors. Additional risk factors are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 7, 2023 and subsequent SEC filings by the Company, including the Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023, filed with the SEC on August 1, 2023. Investors are encouraged to read the Company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties . The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by this cautionary statement.

Contact person for Investor Relations

David Carey
FINN Partners
Phone: 212-867-1762
Email: david.carey@finnpartners.com

Spineway receives 510(k) clearance from the FDA
for its VEOS spinal fixation system

Ecully, October 19, 2023- Spineway Group, a specialist in innovative implants for the treatment of serious spinal conditions, is pleased to announce the recent 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VEOS Spinal Fixation System.

This approval, which allows Spineway Group to commercialize its VEOS system in the US, represents a significant achievement for the Group and reinforces its strategic approach to developing its business in the US market. This recognition also demonstrates the Group’s commitment to providing innovative solutions to surgeons and putting patients’ well-being first.

Presentation at the NASS conference in Los Angeles

This innovative medical device will be presented at the North American Spine Society (NASS) Congress in Los Angeles through October 21, 2023.

The VEOS Spinal Fixation System is a complete platform that provides an innovative and versatile solution tailored to the needs of surgeons. The VEOS platform is easy to use, fully modular and optimizes operational excellence in the operating room.

This new offering enables surgeons to perform open, minimally invasive and percutaneous surgery (MIS) to treat a wide range of spine pathologies, from degenerative spine to complex surgery and deformities.

“We are very proud of this FDA approval, which allows Spineway Group to take the first step in the rollout of its new portfolio in the US. This approval demonstrates our ability to develop innovative solutions for the treatment of spine pathologies that perfectly meet the needs of surgeons and patients. » says Stéphane Le Roux, CEO of Spineway.

Next events:
October 18 to 20, 2023: Participation in the NASS Congress – Los Angeles (USA)
November 10, 2023: Extraordinary General Meeting

SPINEWAY ELIGIBLE FOR PEA-SME (Small and Medium Business Equity Savings Plans)
Find out all about Spineway at www.spineway.com

This press release has been drawn up in both English and French. In case of contradictions, the French version shall prevail.

Spineway designs, produces and sells innovative implants and surgical instruments for the treatment of serious spinal conditions.
Spineway has an international network of more than 50 independent distributors and 90% of its turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specialized in innovation), has received the OSEO Excellence Award since 2011 and the Deloitte Fast 50 Award (2011). Rhône Alpes INPI Patent Innovation Award (2013) – INPI Talent Award (2015).
ISIN: FR001400BVK2 – ALSPW

Contacts:

SPINEWAY Shareholder services line Available from Tuesday to Thursday +33 (0)806 706 060

Eligible PEA/PME ALSPW Euronext growth

HEAVEN Finance & Communications Relations with investors Solène Kennis Spineway@aelium.fr

TAMPERE, Finland, October 20, 2023 /PRNewswire/ — “CORRECTION: Bioretec Ltd is correcting the company announcement published today, October 20, 2023, at 1:00 PM. There was an error in the English version of the release. According to the English version of the press release, the subscription price for a share subscribed with one option right was EUR 2.48. The correct subscription price is 2.84 euros per share. This corrected subscription price has been updated to the announcement below and the attached option plan document 2023-1.

The Board of Directors of Bioretec Ltd decided on October 20, 2023, based on the authorization received from the annual general meeting of the company on May 26, 2023, to introduce a new option program as an incentive scheme for the employees, consultants and members of Bioretec Ltd. the Key Opinion Leader group of the company and its subsidiaries. There is a compelling financial reason for issuing option rights, as the option program is part of the incentive and commitment program of the employees, consultants and members of the Key Opinion Leader group of the company and its subsidiaries.

A total of up to 1,000,000 option rights will be issued, entitling their owners to subscribe to a total of up to 1,000,000 new shares of the company. The option rights are issued free of charge. Based on the option rights, shares can be subscribed as follows:

• 25% of the option rights granted to the holder of the option right: The subscription period for shares starts on the first anniversary of the decision of the Board of Directors to grant the option rights to the holder of the option right;
• the remaining 75% of the option rights given to the option right holder: The share subscription period begins monthly in installments of 1/36th per month on the last day of each month, such that the share subscription period for the first 1/3 The 36th installment commences on the last day of the month following the first anniversary of the decision of the Board of Directors to grant the option rights to the holder of the option right.

The subscription period for the shares ends on December 31, 2029.

After any subscriptions to shares, the shares subscribed for with option rights to be issued will amount to a maximum of approximately 4.9% of all shares and votes of the company. As a result of the subscriptions for shares with option rights, the number of shares in the company can increase by a total of up to 1,000,000 shares.

The subscription price for a share subscribed with one option right is EUR 2.84, which is the trading volume weighted average quotation of the share on Nasdaq Helsinki Ltd, maintained Nasdaq First North Growth Market Finland marketplace from July 19, 2023 to 19 October 2023, increased by 10%.

The subscription price for the shares will be added to the company’s reserve for invested unrestricted equity. The amount of dividends and distribution of assets per share paid will be deducted from the subscription price of the shares.

The theoretical market value of one option right is approximately €1,283 and the theoretical market value of all option rights together is approximately €1,283,357. The theoretical market value of an option right has been calculated using the Black & Scholes valuation model for stock options with the following input factors: valuation date October 19, 2023, share price EUR 2.45, share subscription price EUR 2.84, risk-free interest rate 3.46%, term of option rights 6.21 years and volatility 55.17%.

The target group of the stock option plan includes approximately 35 people. The terms and conditions of the option program are attached to this announcement.

Other questions

Timo Lehtonen, CEO, +358 50 433 8493
Johanna Salko, CFO, +358 40 754 8172

Certified advisor

Nordic certified advisor AB, +46 70 551 67 29

Information about Bioretec

Bioretec is a global Finnish medical device company that continues to pioneer the use of biodegradable orthopedic implants. The company has built up unique competencies at the biological interface of active implants to improve bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used in approximately 40 countries worldwide.

Bioretec is developing the new RemeOs™ product line based on magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable materials for improved surgical results. The RemeOs™ implants are absorbed and replaced by bone, eliminating the need for removal surgery and facilitating fracture healing. The combination has the potential to eliminate the need for titanium implants and help clinics achieve their Value-Based Healthcare goals while focusing on value for patients through efficient healthcare delivery. The first market authorization for the RemeOs™ product was received in the US in March 2023, and in Europe the CE mark is expected to be received in the first quarter of 2024. Bioretec is positioning itself to enter the over $7 billion addressable global orthopedic trauma space. market and become a game changer in the surgical treatment of bone fractures.

Better Healing – Better Living. www.bioretec.com

The following files are available for download:

SOURCE Bioretec

WARSAW, Ind., October 19, 2023 (GLOBE NEWSWIRE) — Orthopediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused solely on advancing the field of pediatric orthopedics, today announced that it has released the new Pediatric Nailing Platform TIBIA System and has successfully completed the first cases of the limited launch has completed. The company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the system in September 2023.

PNP Tibia is part of the Trauma & Deformity Correction product range and represents another pediatric-focused solution for the treatment of patients with lower extremity fractures and deformities. It expands the company’s offering to 52 unique systems specifically designed to help address the needs of pediatric patients. The PNP tibial system features rigid cannulated nails ranging in diameter from 7 mm to 12 mm and includes specialized instrumentation to facilitate multiple surgical techniques. Like other OrthoPediatrics products, this system is designed for the anatomy of children and growing patients.

The versatility and scope of the PNP Tibia System were on full display in these two surgical cases. One case was a trauma procedure for a 6-foot teenager requiring a large nail (12mm x 420mm), while the other was a deformity correction procedure for a 15-year-old of smaller stature requiring a 7mm x 285mm was used. These two cases reflect that OP has the broadest scope of pediatric-focused cannulated nails in the industry, allowing surgeons to treat children of all sizes and needs.

Joe Hauser, president of OrthoPediatrics Trauma & Deformity Correction, said: “It is extremely gratifying to see the system perform successfully in two unique and challenging cases. It shows that the surgeon’s expert design team together with the OP engineers have achieved a goal in designing a system that will help many children for years to come.”

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such, it has developed the most comprehensive product offering for the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 52 systems serving three of the largest categories within the pediatric orthopedic market. This product offering includes trauma and deformity, scoliosis and sports medicine/other procedures. OrthoPediatrics’ global sales organization focuses exclusively on pediatric orthopedics and distributes its products in the United States and more than 70 countries outside the United States. For more information, please visit www.orthopediatrics.com.

Contact person for investors
Philip Trip Taylor
Gilmartin Group
philip@gilmartinir.com
415-937-5406