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Ortoma agrees on term sheet for development and distribution of customized version of OTS Hip

Ortoma AB (publ) (”Ortoma” or the ”Company”) has agreed on a non-binding term sheet with the DePuy Synthes family of companies (“DePuy Synthes”) for the development and distribution of a customized version of the Ortoma Treatment Solution for hip surgery, OTS Hip. The next step in the process is to sign a binding definitive agreement.With the term sheet, the parties have a preliminary understanding of the principal commercial terms for the worldwide distribution rights (excluding Japan) of the customized version of the Ortoma Treatment Solution (Custom OTS) for hip replacement surgery

Strong interest in Ortoma's new 3D modelling concept

Ortoma AB (publ) (”Ortoma” or the ”Company”) today announces that the Company's proof-of-concept presentations of the new technology for converting 2D x-ray images into 3D models, in conjunction with the annual meeting of the American Association of Hip and Knee Surgeons ("AAHKS"), were very successful. The Annual Meeting, which brings together leading orthopedic professionals, was held in Dallas, USA on 4-5 November 2022.Ortoma announced on October 31, 2022, that the Company would present a proof-of-concept solution for converting 2D x-ray images into 3D models built on the Company's

Ortoma completes training session for surgeons ahead of pilot period in Japan

Ortoma AB (publ) (”Ortoma” or the ”Company”) has recently hosted a successful training session for leading Japanese orthopaedic surgeons experienced in assisted surgery. The training prepares the surgeons for the upcoming pilot period and provided Ortoma with important user feedback for future product development.Today, Ortoma is pleased to announce that the Company has recently hosted a successful training session with the Ortoma OTS Hip™ system for leading Japanese orthopaedic surgeons. The training was aimed at ensuring that surgeons are well prepared to adopt the OTS Hip technique

Ortoma presents breakthrough 3D concept for orthopedic surgery at AAHKS Annual Meeting in Dallas

Ortoma AB (publ) ("Ortoma" or the "Company") announces today that the Company has initiated development in a new potential business area for the conversion of 2D x-ray images into 3D models based on the Company's unique AI platform. The concept will be unveiled in conjunction with the American Association of Hip and Knee Surgeons ("AAHKS") Annual Meeting in Dallas, USA later this week from 4 to 5 November, 2022.Ortoma has demonstrated a “proof of concept” solution for converting 2D x-ray images into 3D models based on the Company's unique AI-based preoperative planning platform. This proof

Ortoma Signs Agreement for Exclusive Distribution Rights in Japan

Ortoma signs agreement with Johnson & Johnson K.K. for exclusive distribution rights in Japan of the Ortoma Treatment Solution for hip surgery. It is the first agreement that the company executes with a global strategic partner. The agreement allows for the possibility to expand the partnership to other global markets.Ortoma is the provider of the Ortoma Treatment Solution (OTS), which includes OTS Hip Plan and OTS Hip Guide for pre-operative planning, intra-operative navigation, and post-operative follow-up of hip implant surgical procedures. The OTS platform is a surgical system that is

Ortoma obtains JP certification for hip implant planning module

Ortoma has obtained certification in Japan for its module OTS Hip Plan for pre-operative planning of hip replacement surgery. The marketing approval is an important step for launching OTS Hip, including modules for pre-operative planning and navigation of orthopedic hip implants, in Japan. The OTS platform is a surgical system that is assisted by AI (Artificial Intelligence) for improved accuracy, efficiency and surgical outcome.Ortoma has a strategy to offer OTS Hip Plan for pre-operative planning in a stand-alone version as well as bundled with OTS Hip Guide for computer-assisted

Ortoma has Agreement on Non-binding Term Sheet for Exclusive Distribution Rights in Japan

Ortoma has agreement on a non-binding term sheet with a major global orthopedics implant and MedTech manufacturer for exclusive distribution rights of the Ortoma Treatment Solution for hip surgery in Japan. The next step in the process is to sign a binding definitive agreement.With the term sheet, the parties have a preliminary understanding of the principal commercial terms for the distribution rights of Ortoma Treatment Solution (OTS) in Japan. The term sheet covers exclusive distribution rights for OTS for hip replacement surgery including the products OTS Hip Plan and OTS Hip Guide for

Ortoma Submits US FDA 510(k) Application for Spine Module

Ortoma has submitted a regulatory application for FDA 510(k) clearance of its spine module to be included in the platform Ortoma Treatment Solution (OTS). The spine module is a pre-operative planning solution for spine surgery. The OTS platform is a surgical system that is assisted by AI (Artificial Intelligence) for improved accuracy, efficiency and surgical outcome.The submission has been accepted for review by the US FDA (US Food & Drug Administration). The result of the review is expected during the 2[nd] half-year 2021. After receiving FDA 510(k) clearance, the product will be

Ortoma obtains CE certification for Spine Module

Ortoma has obtained CE certification for its spine module OTS Spine Plan now included in the platform Ortoma Treatment Solution (OTS). The spine module is a pre-operative planning solution for spine surgery. The OTS platform is a surgical system that is assisted by AI (Artificial Intelligence) for improved accuracy, efficiency and surgical outcome.CE certification for OTS Spine Plan is approved by the Notified Body and the CE-marked product is approved for use clinically in Europe. The OTS platform now includes CE marked products for hip replacement surgery and spine surgery.  In addition,

Ortoma Submits Application for CE-mark of Spine Module

Ortoma has submitted a regulatory application for CE-mark of its spine module to be included in the platform Ortoma Treatment Solution (OTS). The spine module is a pre-operative planning solution for spine surgery. The OTS platform is a surgical system that is assisted by AI (Artificial Intelligence) for improved accuracy, efficiency and surgical outcome.The submission will be reviewed by the Notified Body. Their CE assessment is expected to be completed during the second quarter of 2021. After obtaining the CE-mark, the product will be available for use clinically. “The development of

Ortoma Obtains Granted Patent in the USA

Ortoma has been granted another patent by the US Patent and Trademark Office (USPTO). The patent relates to Ortoma Guide, which is a part of the innovative surgical system Ortoma Treatment Solution (OTS), and protects the system including accessories for navigated surgery.The patent complements the company’s patent protection in the USA and covers all types of implants. The invention protected by the patent is one of the core technologies for the surgical system OTS, and is used to guide implants with high accuracy during surgery. The patent also covers accessories for OTS, that were

Ortoma launches new website highlighting market leading AI-assisted surgical solutions

Ortoma is now entering the commercialization phase of Ortoma Treatment Solution™ (OTS™) its AI assisted surgical technology platform for planning and positioning of orthopaedic implants. To emphasize some of the key features, the company has launched a new website: www.ortoma.comOTS™ is an orthopedic digital, server-based integrated AI platform designed to optimize patient outcomes through surgical planning, precision surgical navigation, post-operative verification, and follow-up. This platform is used at the point of care and provides immediate integration into the hospital system. The

Ortoma launches OTS 5 according to plan

Ortoma, manufacturer of surgical assistive technology for planning and positioning of implants, launches the latest version of the company’s surgical system Ortoma Treatment Solution (OTS), which is based on AI (Artificial Intelligence). Ongoing active market feedback has revealed unmet clinical needs that are met by the improved OTS system. The system is developed as a platform for surgeries with orthopedic implants, and has marketing approval in Europe and USA. Accessories to OTS have been developed for use with surgical instruments, which further reduces surgery time and increases the

World-class Performance with Assistance of Artificial Intelligence

In the latest version of Ortoma Treatment Solution, OTS 4, Ortoma has introduced support of Artificial Intelligence. The system drastically reduces the time needed for pre-operatively planning of a hip implant in 3D, which has created a big interest for the company’s unique solution.Performance has been a focus area during the development of the latest version of Ortoma Treatment Solution (OTS). With OTS 4, an automatic AI-analysis, which forms the basis for the pre-operative planning, is made. The analysis does not take more than about 30 seconds and includes a suggestion for suitable

Ortoma initiates expansion with module for spine surgery

Safer and more accurate surgical outcome of spine surgery with Ortoma’s surgical system After a period of assessment of Ortoma’s surgical system for hip surgery, the company is now taking the step next step and initiates expansion of Ortoma Treatment Solution (OTS) with a module also for spine surgery.– The conclusion after a number of performed surgeries is that our surgical system provides distinct advantages including very high accuracy and safety, which is decisive for the surgical outcome also for spine surgery. Therefore, the board of directors has taken the decision to expand the

Ortoma continues to explore market opportunities on non-exclusive basis

After a preliminary review of the possible opportunities by both companies, both Ortoma and the European Company (previously announced as having an exclusive negotiation period with Ortoma) have mutually agreed to continue exploring possible market commercialization opportunities on a non-exclusive basis. While it’s apparent there are market synergies between both companies, initial assessments from our M&A Advisor indicated that both parties may currently lack the global presence required to drive maximum key stakeholder value from a worldwide investment and/or marketing agreement.

Ortoma Engages M&A Advisor

Ortoma and the Board of Directors have engaged MedWorld Advisors (www.medworldadvisors.com) as M&A advisor to assist the company and the Board with management, evaluations, and negotiations in connection with any M&A transaction.During the past year, the company have had discussions with potential industrial partners as a part of taking its product Ortoma Treatment Solution to the market. MedWorld Advisors will take over the contacts that have been generated by the company, broaden and intensify the evaluation, and negotiate with potential acquirers and industrial partners. Linus Byström,

Ortoma signs exclusivity agreement

Ortoma has signed an exclusivity agreement under a memorandum of understanding (MoU) with a European company that has Chinese ownership interests. With the MoU, Ortoma undertakes not to initiate discussions or negotiations with other companies with headquarters in Asia until June 30, 2019. The agreement gives the counterparty the opportunity to continue evaluating Ortomas technology and negotiating commercial terms with under a limited exclusivity.At the beginning of the year, the companies evaluated the opportunities for collaboration to take the Ortoma Treatment Solution (OTS) to the

Ortoma AB receives administrative acceptance review from FDA for Ortoma Treatment Solution™

FDA writes “An administrative acceptance review was conducted on your premarket notification (510(k)) K172515/S002, and it was found to contain all of the necessary elements and information needed to proceed with the substantive review.”  “- It is an extensive work with the FDA application that now enters its final phase. An approval from FDA opens the big American market for Ortoma, says CEO Matts Andersson.” For further information, please contact: Prof. Gunnar Németh, MD, PhD, Chairman of the BoardMobile: +46 70-529 20 00e-mail: gunnar@nemeth.se About Ortoma AB (publ)

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