Marketed as a health/wellness tool (not to be confused with a medical device), the iHeart device team pitched their product to the Dragons recently. Mary Teresa Bitti at the Financial Post provides a summary of the pitch and the outcome.
Canada-based 3D4M successfully tested 3D printing of two models of finger splints making medical device headway in the new frontier
TORONTO, CANADA — (January 31, 2017) – Antibe Therapeutics Inc. (“Antibe”) (TSXV: ATE, OTCQX: ATBPF) today announced that its subsidiary Citagenix Inc. (“Citagenix”) has launched PentOS OI™ Max for the dental biologics market. PentOS OI™ Max is the newest member of the PentOS OI™ family of bone grafts for oral and maxillofacial surgery.
PentOS OI™ Max is an inductive collagen matrix that can be mixed with the clinician’s choice of patient derived concentrates (including stem cells and blood components). Osteoinductivity is demonstrated in each lot in both in vivo and in vitro assays using independent laboratories. In vitro testing demonstrated levels of bone morphogenetic protein (“BMP”) up to 40-times that of the control. BMP is a naturally occurring growth factor found in the human body and plays a crucial role in bone formation. In vivo testing demonstrates all five elements of bone formation are present in our PentOS OI™ grafts: chondrocytes, osteocytes, bone marrow cells, cartilage, and new bone. In vitro studies also demonstrated excellent cell viability and proliferation.
“Citagenix continues to augment its portfolio with the addition of high-quality products that support optimal patient outcomes at a competitive price point,” said Dan Legault, Antibe’s CEO. “Being the ‘portfolio-of-choice’ for dentists and oromaxillofacial surgeons is important to our global growth strategy and is supported by an active business development funnel.”
PentOS OI™ Max will be offered in the Canadian market through our direct sales force and globally via our network of distribution partners. To learn more about the PentOS OI™ suite of products, please visit the product website: www.PentOS-OI.com
Antibe develops safer medicines for pain and inflammation. Antibe’s technology involves linking a hydrogen sulfide-releasing molecule to an existing drug to produce a patented, improved medicine. Antibe’s lead drug ATB-346 targets the global need for a safer drug for chronic pain and inflammation. ATB-352, the second drug in Antibe’s pipeline, targets the urgent global need for a safer, non-addictive analgesic for treating severe acute pain, while ATB-340 is a GI-safe derivative of aspirin. www.antibethera.com
Antibe’s subsidiary, Citagenix Inc. (“Citagenix”), is a leader in the sales and marketing of tissue regenerative products servicing the orthopedic and dental marketplaces. Since its inception in 1997, Citagenix has become an important source of knowledge and experience for bone regeneration in the Canadian medical device industry. Citagenix is active in 15 countries, operating in Canada through its direct sales teams, and internationally via a network of distributor partnerships. www.citagenix.com
Neither the 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.
This news release includes certain forward-looking statements, which may include, but are not limited to, the growth of product sales, engaging new distributors and independent representatives, the completion of financing transactions and the licensing and development of drugs and medical devices. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “will”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and similar expressions. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the Company’s ability to secure additional financing, its ability to execute its business strategy and successfully compete in the market, and risks associated with drug and medical device development generally. Antibe Therapeutics Inc. assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.
Antibe Therapeutics Inc.
Chief Executive Officer
Tel: +1 416-473-4095
RCI-02, RepliCel’s nearest-term commercial asset, enables game-changing reliability, reproducibility, and programmability of three-dimensional skin injections
VANCOUVER, BC – February 9, 2017 – RepliCel Life Sciences Inc. (OTCQB:REPCF) (TSXV:RP) (FRA:P6P2) (“RepliCel” or the “Company”), a clinical stage regenerative medicine company developing unique biologic products for pattern baldness and thinning hair, aging and sun-damaged skin, and chronic tendon degeneration, today announced the granting of two patents in Europe related to its multi-needle dermal injection technologies.
The first patent, European Patent No. 2623146, has been validated in a total of fourteen national countries, including Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Switzerland, Sweden and the United Kingdom. The second patent, European Patent No. 2809381, will also be validated in a number of European countries in the near future.
The first device being developed under these patents, RCI-02, is designed for injecting hyaluronic acid (“HA”) and other products as dermal fillers. The device is also being developed for the injection of RepliCel’s RCH-01 hair restoration and RCS-01 skin rejuvenation products. Future iterations of the technology and device will be optimized for other injectables such as drugs, biologics, vaccines, fat grafts, etc.
“These patents are an important milestone for the Company as it underpins the near-term commercial value of RCI-02 for the delivery of other injectables beyond our own products. RCI-02 coupled for the injection of dermal fillers and other aesthetic treatments represents an early opportunity for licensing and revenue,” stated RepliCel CEO Lee Buckler. “This year we will build and test commercial-grade functioning prototypes with the goal of having it ready for a CE-mark application and potential market launch in 2018. Ongoing discussions with several multinational companies about potential commercial partnerships for the device give us confidence this represents one of RepliCel’s next licensing deals. ”
Overall benefits of this next-generation dermal injector technology are anticipated to include improved handling, reduction or elimination of the need for local anesthetic, quicker procedure times, improved patient experience, and a significant expansion of the areas that can be addressed with dermal fillers due to the ability to conduct broad, shallow, and evenly-dispersed injections. Additionally, the device’s simplicity and programmability is expected to enable less-experienced injection specialists to deliver predictable and consistent outcomes.
“RCI-02 was originally conceived to deliver our cellular products; however, we believe this device will have a profound impact on all dermal injections – particularly in the cosmetic dermal injection market. For the first time, the dermatology sector will be given a device, RCI-02, which enables clinicians unprecedented reliability, reproducibility, and programmability of three dimensional skin injections,” commented Dr. Rolf Hoffmann, RepliCel’s Chief Medical Officer, who is a practicing dermatologist and is the visionary for the RCI-02 injector. “Dermatologists have been hindered for years by a single needle syringes’ inability to precisely deliver approved dermal fillers into fine wrinkles of the face, décolleté, and hands. RCI-02 is designed to address these unserved markets while also improving on current markets by enabling precise and repeatable delivery of injectable substances. RCI-02 will enable clinicians to better control injection consistency while also enabling less skilled clinicians to undertake these procedures with the desired results.”
“In addition to the near-term commercial opportunity RCI-02 represents for revenue generation, we believe ensuring the optimal and controlled delivery of our cell-based products will be an important component to the commercial value we are creating around the development of our products for both aging or sun damaged skin and pattern baldness,” commented Lee Buckler, CEO.
The RCI-02 injector was designed with input from dermatologists, industrial designers, and electronic and medical device engineers to improve the delivery of a variety of injectables in a controlled, precise manner, removing the risks and uncertainties of injection outcomes currently resulting from manually operated, single-needle syringes.
RCI-02 is the world’s first motorized injection device with programmable depth and volume, a built-in Peltier element for pre-injection anaesthetising, and interchangeable needle head configurations. It is designed to deliver a variety of injectable substances including cells, dermal fillers, drugs or biologics intradermally (dermis), subcutaneously (fat) or intramuscularly (muscle) via an array of needle configurations ranging from a single needle to a 16 needle configuration (4×4) on one head. These interchangeable heads can be used to perform a variety of procedures, increase surface area coverage and speed-up procedure times.
By relying on electrical power (instead of thumb pressure) and digital controls, RCI-02 automates and simplifies the injection process. Equipped with a touch screen on its accompanying docking station, the device’s programmability allows for the delivery of precise quantities of material, at specific depths, through fine-gauge needles, on a single plain or trailing through multi-plains as the needle retracts through the skin.
The near-term commercial opportunity for RCI-02 is to improve the injection of is hyaluronic acid-based dermal fillers. RepliCel’s dermatologist advisors believe this device has the potential to significantly expand the number of HA dermal injection procedures currently performed. As an example, the HA market in the United States is currently valued at over US$1 billion per year and is growing at near double digits. These HA injections primarily address deep facial wrinkles and folds, but do not adequately address fine wrinkles. A device, such as RCI-02, which is capable of delivering a controlled injectable, utilizing a multi-head configuration, and eliminating the need for local anesthetic, has the potential to dramatically increase the HA market into new areas including the fine wrinkles of the face, the hands and the décolleté.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of two ongoing clinical trials (RCT-01 for tendon repair and RCS-01 for skin rejuvenation) as well as its RCH-01 hair restoration product under exclusive license by Shiseido Company for certain Asian countries. All product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles. RepliCel has also developed a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit http://replicel.com/ for additional information.
For more information, please contact:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / email@example.com
This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding: (i) that the dermal injector device will result in a near term commercial opportunity for revenue generation; (ii) that the dermal injector will improve the injection of hyaluronic acid-based dermal fillers; (iii) that the device’s simplicity and programmability is expected to enable less-experienced injection specialists to deliver predictable and consistent outcomes; (iv) that the dermal injector will be RepliCel’s next licensing deal; (v) that the dermal injector, once developed, will represent game-changing reliability, reproducibility, and programmability of three dimensional skin injections; (vi) that future iterations of the technology and device will be optimized for other injectables such as drugs, biologics, vaccines, fat grafts, etc.; (vii) that the device will be ready for a CE-mark application and potential market launch in 2018; (viii) that the overall benefits of dermal injector technology include improved handling, reduction or elimination of the need for local anesthetic, quicker procedure times, improved patient experience, and a significant expansion of the areas that can be addressed with dermal fillers due to the ability to conduct broad, shallow, and evenly-dispersed injections; (ix) that the device will have a profound impact on all dermal injections; and (x) the dermal injector device will be able to be used for fine wrinkles across broad areas, like fine wrinkles in the face, hands and décolleté. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: the risk that the Company will not obtain CE mark clearance or other necessary regulatory approvals; the risk that there will be delays enrolling clinical trial participants; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risks associated with the Company obtaining approval for its clinical trial in Germany; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2015 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Quark Venture, a venture capital (VC) fund launched in 2016, has followed through with its promise of investing in prominent Vancouver biotech companies. The US$500-million fund — the largest of its kind in Canada — is expected to have a significant impact in the biotech industry both locally and nationwide.
The hospital’s printing lab has been 18 months in the making under the leadership of Rybicki, the Ottawa Hospital’s chief of medical imaging and chair of radiology at the University of Ottawa. He was recruited to come to Ottawa that many months ago from Boston where he long worked in face transplantation involving the use of 3D printing.
MISSISSAUGA, Ontario–(BUSINESS WIRE)–Feb. 9, 2017– Covalon Technologies Ltd. (the “Company” or “Covalon”) (TSXV: COV), an advanced medical technologies company, today announced the issuance of an aggregate of 265,000 stock options to employees and consultants of the Company. The stock options will vest over three years and will be exercisable for a period of five years at an exercise price of $2.20per stock option. The exercise price was set at the closing price on February 7, 2017 in accordance with the Company’s stock option plan.
Covalon Technologies Ltd. researches, develops and commercializes new healthcare technologies that help save lives around the world. Covalon’s patented technologies, products and services address the advanced healthcare needs of medical device companies, healthcare providers and individual consumers. Covalon’s technologies are used to prevent, detect and manage medical conditions in specialty areas such as wound care, tissue repair, infection control, disease management, medical device coatings and biocompatibility. To learn more about Covalon, visit our website at www.covalon.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.
This news release contains forward-looking statements which reflect the Company’s current expectations regarding future events. The forward-looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “plan, “estimate”, “expect”, “intend” and statements that an event or result “may”, “will”, “should”, “could” or “might” occur or be achieved and other similar expressions. These forward-looking statements involve risk and uncertainties, including the difficulty in predicting product approvals, acceptance of and demands for new products, the impact of the products and pricing strategies of competitors, delays in developing and launching new products, the regulatory environment, fluctuations in operating results and other risks, any of which could cause results, performance, or achievements to differ materially from the results discussed or implied in the forward-looking statements. Many risks are inherent in the industry; others are more specific to the Company. Investors should consult the Company’s ongoing quarterly filings for additional information on risks and uncertainties relating to these forward-looking statements. Investors should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update or alter any forward-looking statements whether as a result of new information, further events or otherwise.
Source: Covalon Technologies Ltd.
Innovative Platform Introduces Machine-vision Image Guided Surgery (MIGS™)
LHSC first in Ontario to implant Canadian made mitral valve device
HAMILTON, ON–(Marketwired – January 12, 2017) – Mariner Endosurgery, an innovative Canadian medical device company announced today the recent completion of an investment round led by several prominent medical device investors and leading laparoscopic surgeons from the Toronto – Hamilton area. Terms of the financing were not disclosed.
“We are very pleased with the strategic investors now on board with Mariner Endosurgery,” said Mitch Wilson, President & COO of Mariner Endosurgery. “Surgeons are excited about our innovative product pipeline, and today’s funding represents a significant step towards commercialization of our LaparoGuard technology. Mariner’s computer-assisted platform provides augmented visualization for surgeons during minimally invasive general, gynecological and urological surgical procedures.”
About Mariner Endosurgery Inc.
Founded in 2016, Mariner Endosurgery Inc. http://marinerendosurgery.com develops and commercializes innovative computer assisted medical devices for future-facing laparoscopic surgeries. Their platform LaparoGuard is a novel soft-tissue surgical navigation platform that augments visualization during laparoscopic surgeries, enhancing the safety profile of laparoscopic surgery to assist surgeons in delivering a superior quality of care to their patients.