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December 11, 2017

FDA Approves Investigational Device Exemption for SetPoint Bioelectronic Therapy Clinical Study in Rheumatoid Arthritis


SetPoint Medical has received Investigational Device Exemption (IDE) approval from the U.S. Food & Drug Administration (FDA) to initiate a pilot trial in the U.S. for patients with drug refractory rheumatoid arthritis (RA). SetPoint’s proprietary bioelectronic device will be surgically placed on the vagus nerve and activated based on a predetermined dosage schedule to evaluate safety and efficacy.



This multi-center study, “A Randomized Controlled Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients with Rheumatoid Arthritis,” will assess the safety and efficacy of SetPoint’s proprietary bioelectronic device in adult patients with RA who have failed multiple biologic agents. A total of 15 subjects, aged 22 to 75, will be enrolled across seven U.S. investigational centers.



The new trial will evaluate SetPoint’s proprietary miniaturized, rechargeable wireless implanted device. This novel device will be used to stimulate the vagus nerve in order to activate the efferent arm of the Inflammatory Reflex known as the Cholinergic Anti-inflammatory Pathway (CAP). SetPoint is developing a proprietary bioelectronic medicine platform that activates the body’s natural Inflammatory Reflex in order to activate systemic anti-inflammatory pathways. The emerging field of bioelectronic medicine aims to address unmet patient needs by delivering targeted digital doses to modulate physiological circuits for treatment of diseases historically treated with drugs.



See more about the SetPoint Implantable Neuromodulation Device on Meddevicetracker.



Medherant Completes €3.8 Million Funding Round


Medherant has raised £3.8 million in its latest funding round. The fundraising was led by majority shareholder Mercia Technologies PLC, with the balance coming from other existing shareholders as well as new private investors. This latest investment will support the company as it progresses its ibuprofen TEPI Patch into clinical development in early 2018.



Medherant’s next-generation drug delivery platform, TEPI Patch, overcomes many of the limitations of patches currently on the market, and can deliver drugs to act locally or systemically. TEPI Patch is compatible with a wider range of drugs and has a greater loading capacity than other drug-in-adhesive patch technologies enabling more drug to be delivered. The novel adhesive used by Medherant also provides an enhanced patient-user experience being thin and comfortable, with strong adhesion and painless removal without leaving any residues. The company has completed non-clinical work on its lead product, ibuprofen TEPI Patch, and is currently working with AdhexPharma to manufacture product, ready for clinical trials in Spring 2018.



See more about the TEPI Patch on Meddevicetracker.



Mainstay Medical Announces Positive Outcome of Interim Analysis


Mainstay Medical announced a positive outcome of the Interim Analysis in its U.S. Pivotal ReActive8-B Study, comprising a definitive size and an estimated completion date.



Key updates relative to this study, and its design, are as follows:


  • The Study utilizes an adaptive trial design, inclusive of an Interim Analysis, to determine the definitive size of the Study of up to 232 patients in the pivotal cohort. With this adaptive design, Mainstay commenced the Study with a sample size of 128 patients pending the Interim Analysis;

  • The independent Data Monitoring Committee (DMC) has completed the Interim Analysis, which is based on data from the first 58 patients in the pivotal cohort to complete the primary endpoint. The DMC has recommended continuation of the Study with a definitive size of 168 evaluable patients. The ultimate number of patients in the Study will be slightly higher than 168 due to the nature of the enrollment process;

  • The DMC also reported that they have observed no safety concerns in the Study; and

  • The Study is expected to be fully enrolled by the end of the second quarter of 2018, and the Company expects to announce full data readout towards the end of 2018.


133 patients have been implanted in the pivotal cohort in the Study to date and clinical study sites have continued to implant patients pending the outcome of the Interim Analysis. The Study is intended to gather data in support of an application for pre-market approval (PMA) from the U.S. Food and Drug Administration (FDA), a key step towards commercialization of ReActiv8 in the U.S.



See more about the ReActive8 on Meddevicetracker.





December 12, 2017

Myriad’s BRACAnalysis CDx Test Effectively Identified Metastatic Breast Cancer patients with Improved Outcomes from Pfizer’s PARP Inhibitor, Talazoparib


 Myriad Genetics announced that data from the EMBRACA trial showed Myriad's BRACAnalysis CDx test successfully identified patients with metastatic breast cancer (MBC) who responded to Pfizer's investigational PARP inhibitor, talazoparib. The EMBRACA trial data were presented at the 2017 San Antonio Breast Cancer Symposium (SABCS) on December 8, 2017.



The study included approximately 400 patients, all of whom tested positive for germline BRCA mutations as determined by Myriad's FDA-approved BRACAnalysis CDx test. As presented at SABCS, the results demonstrated that patients with gBRCA+ locally advanced and/or MBC demonstrated superior progression-free survival (PFS) in patients treated with talazoparib, compared to patients who received physician's choice standard-of-care chemotherapy. Additionally, the PFS benefit was consistent across metastatic BRCA-positive patients, including those with hormone receptor-positive and triple negative disease.



BRACAnalysis CDx is the only germline companion diagnostic test approved by the FDA to identify patients with BRCA1/2 mutations. The collaboration to develop a novel companion diagnostic test for talazoparib was announced in October 2013. Myriad submitted a supplementary premarket approval (sPMA) application to the U.S. Food and Drug Administration (FDA) under its existing PMA for BRACAnalysis CDx to include talazoparib in October 2017.



See more about the BRACAnalysis Companion Diagnostic on Meddevicetracker.



Two Centers from The US Oncology Network Adopt iCAD’s Xoft Electronic Brachytherapy System for Treatment of Early-Stage Non-Melanoma Skin Cancer


iCAD announced that its Xoft Axxent Electronic Brachytherapy (eBx) System is now available at two California-based centers from The US Oncology Network: Santa Clarita Radiation Therapy Center and Sherman Oaks Radiation Therapy Center. Local patients with non-melanoma skin cancer (NMSC), including individuals precluded from surgery or those seeking a non-invasive option, will now have access to a proven alternative that has successfully treated more than 10,000 individuals worldwide.



Appropriate candidates include NMSC patients with lesions in anatomically challenging locations such as the ears, nose, scalp, neck, shin, and elbows, as well as those with wound healing challenges, individuals taking anticoagulants, and patients with medical comorbidities that may prohibit them from surgery.



The Xoft technology features a miniaturized, low-energy X-ray source that delivers a precise dose of targeted, isotope-free radiation directly to the lesion, reducing the risk of damage to surrounding healthy tissue. The mobile system can be easily maneuvered from room-to-room, while minimal shielding requirements enable clinicians to deliver treatment in a standard exam room, offering a highly-efficient, flexible solution.



See more about the Axxent Electronic Brachytherapy System on Meddevicetracker.



December 13, 2017

Cellnovo Announces the CE Marking of the First Bluetooth and Android-enabled Micro-Pump for Insulin Delivery


Cellnovo announced the CE Marking of its next-generation mobile diabetes management system. The next-generation Cellnovo System utilizes Bluetooth Low Energy and the Android operating system. The use of the wireless communication technology and a standard mobile operating system will further enable interoperability with other e-health platforms, including artificial pancreas projects.



The Cellnovo System is a mobile, connected, all-in-one diabetes management system with an e-connected micro-pump, which provides real time data to patients and clinicians.



The company's next-generation system, the Cellnovo with Android, builds upon the current system in three main aspects:


  • The adoption of standard technologies will facilitate the interoperability of the Cellnovo System with other connected objects for health and well-being. The next-generation system will thus be capable of communicating with devices such as continuous glucose meters, blood glucose meters, fitness trackers, and smart watches, providing a holistic vision of the patient’s health. These innovations aim to provide Cellnovo with a best-in-class platform to be used for the Company’s future artificial pancreas and automated insulin delivery (AID) product lines.

  • The Cellnovo micro-pump will communicate wirelessly with the touchscreen handset using Bluetooth Low Energy, a standard communication technology dedicated to connected objects. This technology guarantees the quality of communications while significantly reducing energy consumption.

  • The use of the Android operating system improves the performance of Cellnovo's proprietary touchscreen handset.



See more about the Cellnovo System on Meddevicetracker.



Medtronic Wins CE Mark for Endurant Stent Graft, HeliFX EndoAnchor Combo


Medtronic announced it has received CE Mark approval in the European Union for combined treatment with its Endurant II or IIs stent graft and the Heli-FX EndoAnchor system in patients with short aortic anatomies.



The combined treatment is now cleared with indications to that patients with aortic neck lengths down to 4mm with a less than or equal to 60 degree infra-renal angulation, according to the Company. Medtronic also announced that the new indication was formally launched in the European Union.



See more about the Endurant II Stent Graft System on Meddevicetracker.


PQ Bypass Receives Conditional IDE Approval to Initiate Study of First-of-its-Kind Procedure for Patients Suffering From Peripheral Artery Disease


PQ Bypass announced that the company has received conditional approval of its investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate the pivotal DETOUR II clinical trial. As one of the first-ever pivotal trials for percutaneous femoropopliteal bypass, DETOUR II will evaluate the safety and effectiveness of the DETOUR System in up to 292 patients with lower limb ischemia due to long blockages (>15 cm) in the superficial femoral artery (SFA) caused by peripheral artery disease (PAD).



DETOUR II is a prospective, single-arm, global multi-center trial and will be conducted at up to 40 sites to enable the collection of safety and effectiveness data in support of a pre-market approval (PMA) submission to the FDA. Additionally, to demonstrate health economic outcomes, the trial includes a prospective economic study designed to collect data related to the costs associated with treating PAD in the study population. An economics core lab will lead the collection of quality-of-life outcome measures (collected at baseline, 30 days, six and 12 months), and procedural and follow-up costs, including rehospitalizations, through 24 months.



Percutaneous femoropopliteal bypass (the DETOUR procedure) is an entirely new procedure enabled by PQ Bypass’ proprietary DETOUR System, which is comprised of the TORUS Stent Graft, DETOUR Crossing Device, and DETOUR Snare. The DETOUR procedure creates a pathway that originates in the SFA, travels through the femoral vein and ends in the popliteal artery, bypassing the diseased part of the artery. This pathway allows TORUS Stent Grafts to be placed in a continuous line and consistently re-direct oxygen-rich blood around the blockage, restoring blood flow to the lower leg and foot of the patient. Unlike existing technologies such as stents and drug-coated balloons, which merely create a channel through the disease and are not designed for extremely long blockages, the DETOUR procedure is a unique solution designed to provide the durability of open bypass surgery but with a minimally invasive approach.



See more about the PQ Crossing Device, PQ Snare, and PQ Stent Graft on Meddevicetracker.





December 14, 2017

Companion Medical Announces U.S. Commercial Launch of Smart Insulin Pen System


 Companion Medical announced that it has begun commercial sales of the InPen system in the United States. InPen is available by prescription only and is a covered benefit under many insurance plans. The InPen is for use with U-100 Lilly Humalog and Novo Nordisk Novolog rapid-acting insulin and indicated for persons aged 12 years and older.



InPen is a U.S. Food and Drug Administration (FDA) cleared solution that combines an insulin injector pen with a smartphone app and bolus advisor using Bluetooth technology. InPen tracks insulin doses, including priming, and automatically sends the data to the user's mobile device, providing decision support for the constant monitoring and calculating necessary for successful insulin therapy. InPen includes technology to:


  • Calculate and recommend optimal dosing;

  • Track history and timing of doses for a full year;

  • Monitor insulin temperature;

  • Remind the user when to take insulin;

  • Display last dose and insulin-on-board; and

  • Generate actionable reports for the healthcare provider.


The InPen app is compatible with iOS 10 and later and is available on the Apple Store. The app for Android is under development with expected release in the second quarter of 2018. The InPen app allows glucose data from blood glucose meters and continuous glucose monitors to integrate with the app via integration with Apple Health.



See more about the InPen on Meddevicetracker.



OncoSec Announces Dosing of First Patient in Registration-Directed Phase IIb Clinical Trial, PISCES/KEYNOTE-695, of ImmunoPulse IL-12 in Combination with Pembrolizumab


OncoSec announced the initiation of patient dosing in PISCES/KEYNOTE-695, the company's global, multi-center, registration-directed open-label Phase IIb clinical trial. The trial will evaluate the combination of ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or "tavo"] with electroporation), and pembrolizumab in patients with unresectable metastatic melanoma who have progressed or are progressing on an anti-PD-1 therapy. Data from the study are expected in 2018.



The Company's prior Phase II OMS I-102 combination study of ImmunoPulse IL-12 and pembrolizumab in 22 patients unlikely to respond to anti-PD-1 therapy demonstrated a 50% best overall response rate and a 41% complete response rate. In addition, the trial showed a 57% progression free survival (PFS) rate at 15 months (median PFS not yet reached) and 100% (11/11) duration of response. In clinical studies to date, intratumoral tavo has demonstrated a favorable safety profile and has been well tolerated.



PISCES/KEYNOTE-695 is the second combination study conducted with pembrolizumab and, if successful, could form the basis for a BLA under the accelerated approval pathway.



Phase IIb PISCES/KEYNOTE-695 Study

PISCES/KEYNOTE-695 is a global, multicenter Phase IIb, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or "tavo") delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).



See more about the ImmunoPulse System on Meddevicetracker.





December 15, 2017

PolarityTE Announces Application of SkinTE on First Patients


PolarityTE announced that human use of SkinTE is underway, and the product is now on patients, at multiple centers, within a variety of wound types and indications including acute and chronic wounds, burn wounds, surgical reconstructions and scar revisions. In addition, several patients with healed skin grafts, the gold standard treatment, have undergone removal of those grafts and replacement with SkinTE. Multiple medical centers have scheduled additional procedures through the end of 2017, and the Company expects an increasing number of applications during the first half of 2018 to meet market demand for the product. As clinical application grows, results and outcomes from the first group of treated patients are expected to be published throughout the first half 2018, addressing the many different patient populations treated.



See more about SkinTE on Meddevicetracker.

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