MedyMatch Intracranial Hemorrhage Detection Software Receives Expedited FDA Review
Tel Aviv-based MedyMatch Technology recently announced it has received Expedited Access Pathway (EAP) designation from the FDA for its intracranial hemorrahage (ICH) detection software medical device.
According to Gene Saragnese, Chairman & CEO of MedyMatch, the platform is a “first-in-class hemorrhage detection tool.” The MedyMatch device utilizes artificial intelligence and deep learning technologies to analyze non-contrast head CT images for signs of ICH. Further implementations of the MedyMatch deep vision platform include diagnosis and monitoring of acute and chronic diseases based on concurrent analysis of imaging data and other patient data. Vice President of Clinical, Regulatory, and Quality Affairs, Dr. Joshua Schulman, said:
This designation is a recognition of both the need for new assessment tools for intracranial hemorrhage and an affirmation of MedyMatch’s technical approach to assisting clinicians to need to make time-sensitive yet accurate decisions in emergency settings.
The EAP Program, intended to speed approval of certain medical devices, generally includes priority review, more interactive review, and senior management involvement. EAP designation can be awarded for devices that address unmet needs for treatment or diagnosis of life-threatening or irreversibly debilitating conditions. It is said to be expected that EAP designated devices will be transitioned to the new Breakthrough Devices program established under the 21st Century Cures Act of 2016.
3D Printing Partnership: 3D Medical Limited to Acquire Mach7 Technologies
3D Medical Limited (ASX: 3DM) recently announced that it has entered into a binding Heads of Agreement (HOA) to purchase 100% of shares issued in Mach7 Technologies. According to the agreement, 3D Medical will issue 460 million shares to the owners of Mach7 in exchange for the company’s assets and intellectual property. Up to 300 million performance shares will also be distributed if predetermined financial milestones are reached. The deal is valued at approximately $60 million USD.
3D Medical Limited is an Australian provider of 3D printing technology and services for use in clinical medicine. The company’s “Touch 3D” service creates 3D printed models from CT or MRI scans. The models may serve as visual aids for pre-surgical planning or be directly implanted during surgery. In June 2015, the company 3D printed a titanium jaw bone that was transplanted into a Melbourne man (Figure 1, right). 3D Medical subsequently received orders for 25 additional custom implants.
Mach7 Technologies is a US based provider of enterprise level medical imaging solutions. Its Mach7 system promotes sharing of data between different departments or facilities and allows the consolidation of images from disparate software platforms. The Mach7 platform is currently used in over 300 sites worldwide, including in leading academic medical centers in the United States.
The proposed merger will give 3D Medical additional exposure in US markets, and provide it with increased control over the 3D printing process from image acquisition through model and implant creation. The company hopes to raise an additional $10.9 million Australian ($7.85 million US) in working capital to support the sales and marketing activity of Mach7, to decrease Mach7’s debt, and to further develop 3D Medical’s data offerings. On October 28th, 3D medical announced that it had raised $4 million through an oversubscribed private placement.
Following the deal, the merged companies will adopt the name Mach7 Technologies and operate out of a Melbourne headquarters. The new company will offer four product lines, including Touch 3D printed models and implants, Mach7 image management solutions, the Visualize holographic projection platform (developed by EchoPixel), and the GestSure in-theater image manipulation system.
3D printing in medicine has gained momentum in recent years and some analysts predict the global market will reach over $965 million by 2019. A variety of 3D printed structures such as teeth, skull, and pelvis have been implanted into human patients, and 3D printed heart models have been used to plan complex surgeries in patients with congenital anomalies (Figure 2, left). Some companies, like San Diego based Organovo (NYSE: ONVO), use human cells in the 3D printing process, which is called bioprinting. Organovo is working with researchers at Yale University to develop bioprinted human organs for implantation, but for the time being, Organovo prints micro-livers for use in drug development. Other companies in the medical 3D printing space include Belgium based Materialise (NASDAQ: MTLS), Michigan based EnvisionTEC, and Minnesota based Stratasys (NASDAQ: SSYS).
Materialise, EnvisionTEC, and Stratasys own a variety of patents related to 3D printing and implants.
Covidien to Acquire Maker of PillCam
According to the Deal Book, the Jewish Voice, and a Covidien press release, Covidien will acquire all outstanding shares of Given Imaging Ltd. in a transaction valued at $860 million. Covidien has agreed to a purchase price of $30.00 per share, which is 127% of Given’s December 6, 2013 closing price.
According to its website, Given is a Yoqneam, Israel-based company that develops technologies, such as the PillCam 3, for visualizing, detecting and monitoring gastrointestinal disorders. The PillCam 3 is described as a capsule used to “visualize and monitor small bowel abnormalities associated with Crohn’s disease, iron deficiency anemia (IDA) and obscure GI bleeding (OGIB).”
According to Covidien’s Group President, Medical Devices & U.S., Bryan Hanson:
We believe GI is one of the most attractive specialty procedure areas. Acquiring Given will enable Covidien to significantly expand its presence in a $3 billion GI market. . . . Adding Given’s portfolio of diagnostics to our portfolio accelerates Covidien’s strategy of providing physicians with products that support the patient along the care continuum from diagnosis to treatment. It also confirms our leadership in developing less-invasive screening, diagnosis and treatment solutions that can improve patient outcomes and lower healthcare costs.
The Jewish Voice reports that Given made the decision to seek a sale or merger after independent investor Discovery Group recommended that the company auction itself off due to the fact that the company “was chronically undervalued” as a result of “mismanagement.”
Given’s CEO, Nachum Shamir, is reported as providing the following comment on the transaction:
After thoroughly evaluating our strategic options we determined that this transaction is in the best interests of Given Imaging, its shareholders and employees. . . .
The deal is expected to close by March 31, 2014.
FDA Approves TouchPACS Imaging Software Suite
DMH International announced today that its subsidiary, Touch Medical Solutions, Inc. (TMSI), has received approval from the United States Food and Drug Administration for TMSI’s “TouchPACS” medical imaging software suite. According to the press release:
TouchPACS is a cutting edge software suite for the PACS medical imaging market (Picture Archiving and Communications Systems). The market was valued at approximately $2.8 billion in 2010 and it is expected to grow to over $5.4 billion by 2017 . . . .
The press release states that DMH International, through TMSI, specializes in PACS, electronic hospital records, electronic medical records, personal health records, medical transcription, and paperless medical office solutions. The press release is available here.
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