Showing all posts written by Robert Hilton
Robert earned his Ph.D. in biochemistry from BYU. His research involved the studies of metals in biological systems, including metal dysregulation in diseases such as chronic kidney disease. Click here to read full bio
On August 23, 2018, Dthera Sciences announced that the Food and Drug Administration granted Breakthrough Therapy designation to its Alzheimer’s disease therapeutic device. According to the FDA, Breakthrough Therapy designation is intended to help patients have more timely access to breakthrough technologies that provide treatment for diseases for which no approved treatment exists or which offer significant advantages over existing treatments. A therapy that receives Breakthrough Therapy designation will be reviewed within 60 days of receipt.
Dthera Sciences chief executive officer Edward Cox stated:
We commend the FDA for recognizing this significant unmet medical need as well as the critical importance of providing innovative new treatments to patients with Alzheimer’s and their caregivers.
According to Dthera Sciences, the therapeutic device, termed DTHR-ALZ, is a prescription digital therapeutic for patients with Alzheimer’s disease. The device digitally delivers ReminX, a reminiscence therapy, to patients with Alzheimer’s disease and automatically optimizes the therapy using biofeedback. Reminiscence therapy is a behavioral intervention that involves introduction of familiar pictures, music, or other materials to help patients reminisce about past experiences.
According to the press release, Alzheimer’s disease is a neurodegenerative disease that is among the ten leading causes of death in the United States. In addition, it is one of the most financially costly diseases. According to Dthera Sciences, DTHR-ALZ mitigates the symptoms of agitation and depression associated with Alzheimer’s disease with minimal investment of time and resources.
On May 30, 2018, the Food and Drug Administration announced the approval of the CustomFlex Artificial Iris. According to the FDA, this is the first approved artificial iris. The approval was granted to Clinical Research Consultants, Inc., and the device is marketed and developed by HumanOptics AG.
The HumanOptics website describes the CustomFlex Artificial Iris as a prosthetic iris used to treat adults and children whose iris is completely or partially missing due to congenital or traumatic aniridia, or other conditions with iris defects. Patients with aniridia experience compromised vision and also suffer from aesthetic defects of the eye. As stated by Dr. Malvina Eydelman, the approval of the CustomFlex Artificial Iris:
provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.
HumanOptics website notes that the CustomFlex Artificial Iris is made of pigmented silicone, and is customizable in size and coloration to fir the needs of each individual patient. It further describes that the artificial iris is inserted into the eye by making a small incision and inserting the folded iris into position, the iris is then unfolded and held in place by the structures of the eye, or by sutures, and mimics the function of the natural iris.
Approval of the CustomFlex Artificial Iris was performed under the compassionate use exemptions of the FDA. The approval proceeded through the premarket approval application (PMA). PMA is the FDA review of Class III medical devices, which include high-risk medical devices. Because the CustomFlex Artificial Iris was classified as a high-risk medical device according to the FDA, it required a PMA pathway in order to obtain marketing approval. This is the most stringent type of device marketing under the FDA, and according to the FDA, approval indicates that the CustomFlex Artificial Iris was shown as safe and effective for its intended uses. In addition, the CustomFlex Artificial Iris was granted Breakthrough Device designation. This program is intended to help patients have more timely access to breakthrough technologies that provide treatment for diseases for which no approved treatment exists or which offer significant advantages over existing treatments.
The Food and Drug Administration recently announced approval of the RadioGenix™ System, a technetium 99m (Tc-99m) generator. The RadioGenix™ System is developed by NorthStar Medical Radioisotopes, LLC, a nuclear medicine technology company.
According to the press release, Tc-99m is a diagnostic agent used in more than 40,000 imaging procedures daily for diagnosis and treatment of patients. Prior to approval of the RadioGenix™ System, Tc-99m could only be produced from enriched uranium in facilities outside of the United States that relied on a complicated and potentially unreliable supply of stable uranium radioisotopes. The development of the RadioGenix™ System alleviates these vulnerabilities by providing a reliable domestic source of Tc-99m.
This radioisotope is vital to disease detection, yet health care professionals have faced challenges with adequate supply due to a complex supply chain that sometimes resulted in shortages. Today’s approval has been the result of years of coordination across the FDA and with U.S. government organizations and marks the first domestic supply of Mo-99 – the source of Tc-99m – in 30 years, which will help to ensure more reliable, clean and secure access to this important imaging agent used in nuclear medicine.
According to NorthStar, the RadioGenix™ System is the first and only device for producing a non-uranium Tc-99m. Rather than uranium, the system uses molybdenite, a naturally occurring molybdenum found in the earth’s crust, as the starting material. Major applications of Tc-99m include detection of potential diseases like coronary artery disease and cancer, as well as evaluating lung, liver, kidney, and brain function.
On July 20, 2017, the Food and Drug Administration announced the clearance of “the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)” to Aspect Imaging Ltd.
According to the news release, the Embrace™ Neonatal MRI gained premarket clearance through a 510(k) submission, demonstrating that the new device is substantially equivalent to a legally marketed predicate device. The Embrace™ system is purported to be a fully enclosed system that does not required a safety zone or a radiofrequency shielded room, and can therefore be placed within the NICU itself.
According to Vasum Peirius, chief medical officer for pediatrics and special populations at the FDA’s Center for Devices and Radiological Health,
“Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population.”
The Embrace™ system’s specifications indicate that it can be used on newborn infants from 2 to 10 pounds and having a head circumference of up to 38 centimeters. According to Aspect Imaging, major applications of Embrace™ include hypoxic-ischemic encephalopathy, periventricular leukomalacia, cerebral infraction, germinal matrix and intraventricular hemorrhage, cerebral hemorrhage, sinus thrombosis, white matter injury, deep gray matter injury, and brain development.
Aspect Imaging Ltd. states on its website that it designs and develops compact magnetic resonance imaging (MRI) and nuclear magnetic resonance (NMR) systems for preclinical, medical, and advanced industrial applications. According to its website, Aspect Imaging has developed compact high-performance permanent magnets that overcome many of the primary drawbacks of traditional MRI systems, including reducing the cost, reducing the complexity, and improving the safety of MRI systems.
On April 12, 2017, the Federal Circuit affirmed the determination by the US Patent and Trademark Office (USPTO), Patent Trial and Appeal Board (Board) that the claims of U.S. Patent No. 8,324,283 (“the ’283 patent”) were invalid as obvious.
US Patent No. 8,324,283
According to public databases, Novartis AG is the assignee of the ’283 patent, directed to pharmaceutical compositions for the treatment of multiple sclerosis. The ’283 patent, according to its abstract, relates to sphingosine-1 phosphate (S1P) receptor agonists and a sugar alcohol suitable for oral administration. According to its label, Gilenya acts by internalizing S1P receptors, which sequesters lymphocytes in the lymph node, to prevent relapse of multiple sclerosis. According to the Food and Drug Administration (FDA), Gilenya, approved in 2010, became the first oral disease-modifying drug approved by the Food and Drug Administration (FDA) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis. A Novartis website states that Gilenya had over $3 billion in sales in 2016.
According to the Federal Circuit Decision, Torrent Pharmaceuticals Limited filed inter partes review (IPR) proceedings of the ’283 patent in 2014. The Board determined that the claims of the ’283 patent were invalid as obvious in its Final Written Decision of September 24, 2015. Novartis appealed the decision to the Federal Circuit, and the Federal Circuit affirmed the Board’s decision.
Federal Circuit Decision
According to the Federal Circuit’s decision, Novartis argued on appeal that the Board “erred in its motivation to combine analysis because it failed to read the prior art as a whole and overlooked critical evidence of . . . known disadvantages” of a claimed active ingredient. However, the Federal Circuit affirmed the Board’s finding, concluding that “substantial evidence supports the Board’s finding that . . . a person of skill in the art would have been motivated to combine” the features of the cited art.
Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a clinical study finding that the Myriad diagnostic device accurately identifies patients for olaparib treatment.
Commenting on the results of the clinical study, Johnathan Lancaster, M.D. Ph.D., Gynecologic Oncologist and Chief Medical Officer of Myriad Genetic Laboratories, stated that:
These outstanding findings represent another meaningful advancement for ovarian cancer patients. Importantly, the results demonstrated that BRCA status as determined by BRACAnalysis CDx can identify patients likely to benefit from PARP inhibition therapy.
According to the press release, the BRACAnalysis CDx® test is an FDA approved diagnostic device that detects and classifies mutations in the BRCA1 and BRCA2 genes, using genomic DNA obtained from whole blood samples from a patient. Mutations in BRCA1 and BRCA2 are known to be associated with Hereditary Breast and Ovarian Cancer (HBOC) Syndrome. These mutations can be detected and quantified using the BRACAnalysis CDx® detection platform. In its Press Release, Myriad announced that BRACAnalysis CDx® may be used to aid in the identifying ovarian cancer patients who would be eligible for treatment with olaparib.
According to its website, Olaparib (Lynparza) is an FDA-approved targeted therapy for cancer, developed by AstraZeneca. Olaparib is a poly ADP ribose polymerase (PARP) inhibitor. Olaparib prevents PARP DNA repair, resulting in a buildup of damaged DNA, and resulting in cell death. Olaparib acts against hereditary BRCA1 or BRCA2 mutations.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Office of AstraZeneca stated that:
We are pleased with the robust improvement in progression-free survival demonstrated by Lynparza in the SOLO-2 trial. We will work with regulatory authorities to make Lynparza tablets available as quickly as possible to patients with ovarian cancer. We remain committed to investigating the full potential of Lynparza, both as monotherapy and in combinations, and to identifying all patients who may benefit from this important medicine.
According to its website, Myriad Genetics is a molecular diagnostic company that develops diagnostic assays for the detection of genetic diseases. Specifically, these assays are said to determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, measure disease activity, and guide treatment decisions. Myriad states that it discovered and sequenced the breast cancer gene, BRCA1 in 1994, and has developed numerous diagnostic products related to the diagnosis of hereditary cancers.
GlaxoSmithKline (GSK) announced that it is partnering with Verily Life Sciences LLC to form Galvani Bioelectronics. According to the press release, GSK and Verily will contribute IP rights and an investment of $712.7 million over seven years.
The new firm, Galvani, is named after the 18th century Italian scientist, physician, and philosopher, Luigi Aloisio Galvani. Galvani was one of the first to explore bioelectronics, and discovered that the muscles of a frog’s legs twitched when the sciatic nerves were stimulated with an electric spark. Galvani’s observations paved the path for the fields of electrophysiology and neuroscience – two pivotal fields in the development of bioelectric medicine.
The press release notes that Galvani Bioelectronics will be a bioelectronics medicine firm, performing research, development, and commercialization of miniaturized, implantable devices that fight diseases by targeting electrical signals in the body. These devices will initially be about the size of a medical pill, with the goal of making them as small as or smaller than a grain of rice. The new devices are said to be designed to function by modifying electrical nerve signals, which could modulate irregular or altered impulses that occur in many illnesses. The press release indicates that these devices may be slated for FDA approval by around 2023.
According to Dr. Moncef Slaoui, who will chair the board of Galvani:
Many of the processes of the human body are controlled by electrical signals firing between the nervous system and the body’s organs, which may become distorted in many chronic diseases. Bioelectronic medicine’s vision is to employ the latest advances in biology and technology to interpret this electrical conversation and to correct the irregular patterns found in disease states, using miniaturised devices attached to individual nerves. If successful, this approach offers the potential for a new therapeutic modality alongside traditional medicines and vaccines.
GSK has been researching these miniaturized medical devices, and published their initial progress in the field in Nature in 2013. Galvani Bioelectronics is 55% owned by GSK and 45% owned by Verily. The company will be based at GSK’s Stevenage research center north of London, with a second research facility in San Francisco. According to Slaoui:
This agreement with Verily to establish Galvani Bioelectronics signals a crucial step forward in GSK’s bioelectronics journey, bringing together health and tech to realise a shared vision of miniaturised, precision electrical therapies. Together, we can rapidly accelerate the pace of progress in this exciting field, to develop innovative medicines that truly speak the electrical language of the body.
Lake Forest, Illinois-based RoundTable Healthcare Partners recently announced an agreement to acquire Symmetry Surgical, Inc. RoundTable states that the acquisition will provide a new platform in surgical instrumentation and specialty devices. According to the press release, RoundTable will acquire Symmetry for a total equity value of approximately $140.3 million. Thomas P. Kapfer, a Senior Operating Partner of RoundTable, will serve as Chairman of the Board of Symmetry. Regarding the acquisition, Mr. Kapfer stated that:
We are very excited to partner with Symmetry. The Company’s comprehensive product portfolio is comprised of well-known brands that are recognized by hospitals and physicians worldwide. We look forward to working with the management team as they continue to serve their customers and grow the business.
Symmetry is a Nashville, Tennessee-based marketer of reusable, reposable, and single-use surgical instrumentation and specialty devices. These devices include a comprehensive variety of surgical instruments, such as calipers, cannulas, curettes, needles, scalpels, specula, and tubes. The press release states that Symmetry’s portfolios include well-known brands such as BOOKWALTER®, GREENBURG®, OLSEN®, QUAD-LOCK®, RAPID CLEAN®, RILEY MEDICAL®, SHARP KERRISONTM, ULTRA INSTRUMENTS®, and VESOCLUDETM.
Craig Reynolds, the Chairman of Symmetry’s Board of Directors, stated that:
The sale of Symmetry to RoundTable will provide our shareholders with immediate and substantial cash value . . . and is in the best interest of all our stakeholders.
Nasdaq’s GlobNewswire describes RoundTable as a private equity firm focused exclusively on the healthcare industry. RoundTable partners with companies that can benefit from its industry relationships and operating expertise and has raised $2.75 billion in committed capital.
West Chester, Pennsylvania-based Animas Corporation recently announced FDA approval for the use of the Animas® Vibe® Insulin Pump and Continuous Glucose Monitoring (CGM) System for children and adolescents, ages two to seventeen. A Johnson & Johnson Diabetes company, Animas brings the industry one step closer to bringing a viable artificial pancreas to the market that is approved for pediatric patients.
Although previously approved for adult patients eighteen and older, children have greater insulin sensitivities than adults, and have a lower compliance with regular injections throughout the day. In addition, parents and caregivers are constantly required to monitor glucose levels and worry throughout the day about injections.
According to Animas, the Vibe System is the only integrated system available for pediatric patients as young as age two. The system allows the patient, and parents and caregivers, to deliver insulin and to monitor glucose trends in children. Diabetes patients, and especially children, cannot always feel the symptoms of when glucose levels are too low or too high, but the Animas Vibe System provides customizable alerts and alarms to provide the information to the patient.
According to John Wilson, Vice President of Insulin Delivery, Animas:
We’re thrilled that the FDA approval of this new indication for the Animas® Vibe® System for the first time now allows children as young as age two access to a CGM-enabled pump.
In its press release, Animas emphasized the value of insulin pump therapy in assisting patients to make more informed decisions about their insulin needs. According to Animas, the therapy has been demonstrated as an effective and significant improvement in blood glucose control compared to multiple daily injections of insulin.