FDA Regulations Allow Medical Devices Clinical Trials To Differ From Pharmaceutical Trials

Palm Beach, FL – March 8, 2019 – Clinical trials are the pathway for new drugs or devices to enter the U.S. and other worldwide markets. However, not all clinical trials are the same…  A recent article by a 20+ year insider in the clinical trial industry said: “While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences in the way the device trials are designed and executed… When studying new drugs, a clinical trial is required. However, when studying medical devices, clinical trials may not be required, depending on the risk stratification (or class) of the device… Generally, the total number needed to treat to demonstrate safety and effectiveness in a device trial is in the hundreds rather than the thousands needed in drug trials.”  In the U.S. the FDA allows the use if Independent Review Boards (IRB) to streamline the approval process. The FDA defines an IRB (and medical devices) as follows: “… an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects… (it) has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects… The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period covered by the original approval.     Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ: SOLY), Bio-Path Holdings, Inc. (NASDAQ: BPTH), ArQule, Inc. (NASDAQ: ARQL), Seelos Therapeutics, Inc. (NASDAQ: SEEL), Eli Lilly and Company (NYSE: LLY).


Approximately 1,700 types of medical devices are regulated by FDA. The range of devices is broad and diverse, including bandages, thermometers, ECG electrodes, IUDs, cardiac pacemakers, and hemodialysis machines.  FORBES calls the medical device market a: “A disruptive market of $410 billion until 2023…


Soliton, Inc. (NASDAQ: SOLY) BREAKING NEWS:  Soliton, a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center (“MD Anderson”), discusses that their RAP device received institutional review board (“IRB”) approval as a non-significant risk device. Subsequent to receiving this status, the Company conducted several human clinical trials to study the use of the RAP device to accelerate tattoo fading and initiated a proof-of-concept trial in humans for the reduction of cellulite.


Soliton’s RAP device accelerates tattoo removal in part by providing dermal clearing of laser-generated vacuoles during laser treatment.  This designation by the IRB allows the Company to use its device in human clinical trials.


The Institutional Review Board (IRB) is an FDA registered constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.


“The NSR designation makes it very straight forward for us to conduct clinical trials with our technology,” commented Dr. Chris Capelli, Soliton’s President and CEO.  “This applies not only to the clinical data we are presenting to the FDA with regard to accelerating tattoo removal, but potential future indications like cellulite reduction.  We believe this allows us to move more quickly in developing Soliton RAP.”      Read this and more news for SOLY athttps://financialnewsmedia.com/news-soly/


Other recent developments in the healthcare, biotech industries:


Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, this week announced a clinical update to the previously reported interim analysis from the Phase 2 trial of prexigebersen (BP1001) for the treatment of acute myeloid leukemia (AML) and provides its plans for the compound’s clinical development moving forward toward registration.


The open-label Phase 2 study in Stage 1 evaluated the efficacy and safety of prexigebersen in conjunction with low dose cytarabine (LDAC), a therapeutic regimen well-established in treatment of AML patients who cannot or elect not to be treated with more intensive chemotherapy.  The primary objective of the study is to determine whether the combination of prexigebersen and LDAC provides greater efficacy than would be expected with LDAC alone in a de novo patient population. Subsequently, Stage 2 of the study added a second cohort that is evaluating the efficacy and safety of prexigebersen in conjunction with Decitabine in addition to the cohort evaluating prexigebersen in conjunction with LDAC.


ArQule, Inc. (NASDAQ: ARQL), recently announced the publication of clinical pharmacodynamic, safety and efficacy data in patients with Proteus syndrome. These data, together with data already presented at ASHG last year, support miransertib’s further development as a potential first systemic treatment for patients suffering from overgrowth diseases, such as Proteus syndrome. The study, published in the American Journal of Human Genetics, and led by the National Institutes of Health (NIH), demonstrated good target engagement, tolerability and reductions in lesion size and pain, especially in children.


Seelos Therapeutics, Inc. (NASDAQ: SEEL), a clinical-stage biopharmaceutical company, announced that it has acquired an exclusive license to intellectual property owned by The Regents of the University of California (The UC Regents) pertaining to a technology that was created by researchers at the University of California, Los Angeles (UCLA). Such technology relates to a family of rationally-designed peptide inhibitors that target the aggregation of alpha-synuclein (α-synuclein). Seelos plans to study this initial approach in Parkinson’s disease (PD) and will further evaluate the potential clinical approach in other disorders affecting the central nervous system (CNS).


This new program will be known as SLS-007. Pre-clinical data provide supportive evidence to slow progression – an early sign of disease-modifying potential in PD.



Eli Lilly and Company (NYSE: LLY) announced this week that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemental Biologics License Application (sBLA) for Emgality® (galcanezumab-gnlm) injection for the preventive treatment of episodic cluster headache in adults. Priority Review aims to expedite the review of applications for drugs that, if approved, could potentially represent a significant advancement in treatment for a serious condition.


The sBLA is based on data from a Phase 3 study that evaluated the safety and efficacy of Emgality (galcanezumab-gnlm) injection 300mg in 106 adult patients with episodic cluster headache. Emgality was previously granted Breakthrough Therapy Designation by the FDA in September 2018 for the preventive treatment of episodic cluster headache, indicating the significant unmet need for this debilitating condition for which there are currently no approved preventive medications.


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