DT MedTech Announces Successful Total Ankle Revision Procedures Using The New Hintermann Series H2™ Tibial Assembly Component and PE Inlay.

February 14, 2018 (Baltimore, MD) – DT MedTech, LLC (DTM) announced today that their new Hintermann Series H2™ Tibial Assembly component and PE inlay have been successfully implanted by Prof. Beat Hintermann in three patients needing total ankle revision surgery. World-renowned foot and ankle surgeon, Prof. Hintermann, developed the new, versatile, two-component, semi-constrained total ankle replacement prosthesis, Hintermann Series H2™, to be used for primary replacement and revision surgery.*

This most recent revision surgery successfully accommodated the position of the patient’s existing anatomy through use of the H2 tibial assembly and PE inlay to convert an unstable, mal-positioned, mobile-bearing tibial component to a semi-constrained prosthesis. According to Prof. Hintermann, the procedure provided stability to the joint with little to no modifications to the existing cuts and anatomy. Postoperatively, patients are able to bear full weigh within the first 24 hours.

Another recent revision procedure resulted in a successful implantation of a functioning H2 ankle to a previously fused ankle due to a mal-alignment from failed arthrodesis surgery. Prof. Hintermann stated, “The new Hintermann Series H2™ is the first customized ankle prosthesis in the marketplace that provides intrinsic stability of the ankle, protecting ligaments and tendons from overload. This reduces pain originating from soft tissue and will provide more stability against translational forces such as walking down the stairs or along uneven ground. Less complications by overloaded periarticular
structures, lowers the incidence for future revisions.”

DTM’s Hintermann Series H2™ sales and distribution in the United States will begin in late March and will be handled directly through its logistics partner, HealthLink Europe International, from its US headquarters in Raleigh, NC, and through specialized and select distributors. Sales and distribution outside of the United States are being handled through HealthLink Europe BV, from its Netherlands location, and other specialized and select distributors.

David Reicher, President and Chief Executive Officer of DTM, stated, “We knew Prof. Hintermann had designed an effective ankle that was versatile and functional when he developed the Hintermann Series H2™ Total Ankle Replacement prosthesis. We are thrilled with the full implantations and revisions we have seen with this exceptional H2 product and are looking forward to its global launch. I believe the Hintermann Series H2™ will be a real game changer within the industry.”

For additional DTM information inside the United States, please email info@DTMedTech.com or call Ms. Jeannie Sarda at +1 410-427-0003; outside the United States, please email dt-medtech@healthlinkeurope.com or call +31 73 303 2537.

* The Hintermann Series H2™ Total Ankle Replacement (Hintermann Series H2™) system is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, replacing flexion and extension movement in the ankle joint, and allowing for movement at the replaced joint. The Hintermann Series H2™ is indicated as a total ankle replacement in primary or revision surgery of ankle joints damaged by systemic arthritis of the ankle primary arthritis), secondary arthritis. The Hintermann Series H2™ is also indicated for patients with a failed previous ankle surgery and revision surgeries following failed total ankle replacement or non‐union/mal‐union of an ankle arthrodesis, provided sufficient bone stock is present. In the United States, this device is intended for cemented use only.

DT MedTech Announces Successful Implantations of the New Hintermann Series H2™ Total Ankle Replacement Prosthesis.

February 7, 2018 (Baltimore, MD) – DT MedTech, LLC (DTM) announced today that Prof. Beat Hintermann, world-renowned foot and ankle surgeon and developer of the new, two-component, semi-constrained total ankle prosthesis, Hintermann Series H2™ Total Ankle Replacement System, has successfully implanted five H2 devices in patients in Liestal, Switzerland. Four of the procedures were primary total ankle replacements and the fifth was a takedown of a mal-position arthrodesis.

The H2 Total Ankle Replacement System is indicated for use as a non-cemented implant outside of the United States and as a cemented implant within the United States, to replace painful arthritic ankle joints due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease (e.g., rheumatoid arthritis, hemochromatosis). The Hintermann Series H2™ can also be used as a revision for failed ankle replacements or non-union and mal-union of ankle arthrodesis.

Prof. Hintermann said, “I am extremely pleased with the outcomes of the recent H2 surgeries performed, especially as the patients were able to bear their own weight just 24 hours after the devices were implanted. Adding this semi-constrained option for my patients alongside the Hintermann Series H3™* mobile-bearing prosthesis, enables me to expand patient selection for total ankle replacements.”

DTM’s Hintermann Series H2™ sales and distribution in the United States will be handled directly through its logistics partner HealthLink Europe International from its US headquarters in Raleigh, NC, and through specialized and select distributors. Sales and distribution outside of the United States will be handled through HealthLink Europe BV, from its Netherlands location, and other specialized and select distributors.

David Reicher, President and Chief Executive Officer of DTM, stated, “We anticipate a limited release of the Hintermann Series H2™ beginning in early February outside of the United States, and in late March within the United States. We have been focused on training, sales, and distribution of the Hintermann Series H2™ in markets around the world and are looking forward to a very successful launch.”

For additional DTM information inside the United States, please email info@DTMedTech.com or call Ms. Jeannie Sarda at +1 410-427-0003; outside the United States, please email dt-medtech@healthlinkeurope.com or call +31 73 303 2537.

*Please note: Hintermann Series H3™ is not available for sale within the United States and its territories.

DT MedTech Announces 510(k) FDA Clearance for Hintermann Series H2™ Total Ankle Replacement System

November 8, 2017 (Baltimore, MD) – DT MedTech, LLC (DTM) today announced that the Hintermann Series H2™ Total Ankle Replacement System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

The Hintermann Series H2™ is a semi-constrained, total ankle replacement prosthesis developed by Prof. Beat Hintermann, a world-renowned foot and ankle surgeon based in Liestal, Switzerland. The Hintermann Series H2™ Total Ankle Replacement System is indicated for use with bone cement to treat ankle arthritis in either primary or revision surgery of ankle joints damaged by systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis), primary arthritis (e.g., degenerative disease), and secondary arthritis (e.g., post-traumatic, avascular necrosis). The Hintermann Series H2™ is also indicated for patients with a failed total ankle replacement or non-union/mal-union of the ankle arthrodesis, provided that sufficient bone stock is present. The Intellectual Property of the Hintermann Series H2™ is protected by numerous patents with additional patents pending.

DTM’s Hintermann Series H2™ sales and distribution in the United States will be handled directly through its logistics partner HealthLink Europe International from its US headquarters located in Raleigh, NC, and through specialized and select distributors.
David Reicher, President and Chief Executive Officer of DTM, stated, “We are extremely pleased to receive marketing clearance from the FDA for our innovative Hintermann Series H2™ Total Ankle Replacement System. I want to thank our employees, M Squared Associates and other advisors, and key stakeholders, who were all so instrumental in helping DT MedTech achieve this momentous milestone.”

DTM continues to market and distribute its Hintermann Series H3™ mobile-bearing Total Ankle Replacement System outside of the United States in over 30 countries. The Hintermann Series H3™ is a substantiated leader for the international ankle replacement market with more than 17 years of proven clinical efficacy outside of the United States.

DTM anticipates a limited release of the Hintermann Series H2™ in early December 2017 outside the United States, as it has already received the CE mark for the device, along with registrations in many additional key markets. DTM will be focusing on training, sales, and distribution of the Hintermann Series H2™ in the United States markets and in markets outside the United States through DT MedTech International Limited (DTMI), DTM’s subsidiary and distribution arm located in Dublin, Ireland, in the upcoming months.

For additional DTM information inside the United States please email info@DTMedTech.com or call Ms. Jeannie Sarda at 410-427-0003; outside the United States, please email dtmedtech@healthlinkeurope.com or call +31 73 303 2537.

*Hintermann Series H3™ is not available for sale within the United States and its territories.

DT MedTech Secures CE Marking and Begins Active Distribution of Hintermann Series H3™ Lower Extremity Medical Devices

August 15, 2016 (Baltimore, MD) – DT MedTech, LLC (DTMT) announced today that having secured CE Marking for the Hintermann Series H3™ total ankle replacement devices, in compliance with mandatory European Directives, they are now actively selling and distributing their products outside the USA.

The DTMT Hintermann Series products for the lower extremity include: (1) Hintermann Series H3™ three-piece Total Ankle Replacement prosthesis, comprising the Standard, Sensitive, and Revision systems (formerly known as the HINTEGRA Total Ankle Replacement prosthesis); (2) Kalix® II subtalar arthrodesis implant to treat flatfoot deformities; and (3) instrumentation to support the implantable devices. Developed by prominent surgeon, Prof. Beat Hintermann, this Total Ankle Replacement system is a proven, dominant player in the ankle replacement market outside the USA with over 15 years of solid clinical efficacy.

The Hintermann Series product line has been approved for use in the following countries: Australia, Austria, Belgium, Canada, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, South Korea, Latvia, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Panama, Portugal, Russia, Sweden, Switzerland, Thailand, UAE, and the United Kingdom.

Distribution channels have been secured to handle products in approved countries, with HealthLink Europe BV delivering the majority of logistics outside the USA.

David Reicher, President and Chief Executive Officer of DTMT, stated, “Through hard work and sheer determination, everyone at DT MedTech can finally see the successful results of their efforts. We thank them all. Any questions our customers may have should be directed to Ms. Jeannie Sarda at info@DTMedTech.com or by calling her at 877-494-2252, in the USA. In addition, customers can contact DT MedTech at CustomerService@DTMedTech.com and DT-MedTech@HealthLinkEurope.com or by calling +31(0)73-3032537, outside the USA.”

DT MedTech Assumes Production and Distribution of Hintermann Series™ Lower Extremity Medical Devices

April 29, 2016 (Baltimore, MD) – DT MedTech, LLC (DTMT) announced today that on May 1, 2016, it will officially take over all production, sales, and worldwide distribution of the Hintermann Series™ lower extremity device product line. Developed by prominent surgeon, Prof. Beat Hintermann, the line includes: (1) Hintermann Series H3™ 3-piece Total Ankle Replacement prosthesis, including the Standard and Revision models (formerly known as the HINTEGRA Total Ankle Replacement prosthesis); (2) the Kalix® II, a subtalar arthroereisis implant to treat flatfoot deformities; and (3) instrumentation to support the implantable devices.

Current manufacturers who have been producing the Hintermann Series products for the past 10 years, will continue to manufacture all products for DTMT, and Healthlink Europe has been contracted to handle the majority of logistics outside of the United States, beginning immediately.

David Reicher, president and chief executive officer of DTMT, stated, “Everyone at DT MedTech is excited to take ownership of this superior, clinically-proven line of the Hintermann Series lower extremity medical devices, and eager to start producing and distributing these life-altering products outside the US.”

“We especially want to thank everyone involved for all of their hard work in making the transition as seamless as possible. We understand there may be issues as we embark on this journey and ask that any questions our customers may have, be directed to Jeannie Sarda at info@dtmedtech.com, or by calling her at 410-494-4994, ext. 250, in the US.”

DT MedTech Acquires Worldwide Ownership of Hintermann Series of Lower Extremity Replacement and Revision Medical Devices

March 3, 2016 (Baltimore, MD) – DT MedTech, LLC (DTMT) announced today that it has successfully completed the acquisition of ownership of the Hintermann Series lower extremity device product line. Developed by prominent surgeon, Professor Beat Hintermann, this exceptional product line includes: (1) the Hintermann Series H3™ 3-piece Total Ankle Replacement prosthesis (formerly known as the HINTEGRA Total Ankle Replacement prosthesis), including a revision platform, and a system available for patients with sensitivities to Cobalt-Chrome alloys; (2) the Kalix® II, a subtalar arthroereisis implant to treat flatfoot deformities; and (3) instrumentation and consumables to support the implantable devices.

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As of May 1, 2016, DTMT will have the exclusive rights to manufacture, distribute, import, export, market, and sell the entire Hintermann Series product line. Current manufacturers, who have been producing the Hintermann Series products for the past 10 years, will continue to manufacture all products for DTMT, and Healthlink Europe will handle the majority of logistics outside of the United States. Currently, the product line is only available outside of the US.

Dr. David Reicher, president and chief executive officer of DTMT, stated, “Our ownership of this superior, clinically-proven line of the Hintermann Series medical devices marks an important milestone for DT MedTech, as we begin to position ourselves as a global leader in lower extremity surgical solutions. Working diligently alongside Professor Beat Hintermann, we plan to expand worldwide distribution of the Hintermann Series H3 Total Ankle Replacement and will introduce Professor Hintermann’s innovative, 2-piece total ankle replacement device in the very near future. We want to assure all surgeons who currently use these products that the newly acquired devices will remain exactly the same in structure and materials. Additionally, we foresee no disruption in terms of product availability.”