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SmartTRAK Life Sciences News and Analysis Blog

Thomas Wallick

30+ years’ experience in Consumer and Life Sciences Industry marketing including Orthopedics and Cardiology.

Recent Posts

6 min read

COVID-19 Surges: The MedTech Industry Reacts

By Thomas Wallick on 7/6/20 4:35 PM

As COVID-19 surges in the United States and around the world, health officials are responding with stern warnings, more testing and cutbacks on closings. While some nations have virtually stopped the spread within their country, MedTech prepares for a post-COVID world and how the virus and the response to it will reshape the industry.

The following is a small sampling of the COVID-19 updates compiled, reviewed and posted in real-time by our SmartTRAK analysts, who are constantly monitoring the situation and sifting through the noise to present the most relevant news to our subscribers:

Study Projects COVID Impact on US Healthcare

A statistical analysis study concluded elective procedure deferment during the COVID-19 pandemic will have a lasting impact on the US healthcare system and could result in a cumulative backlog of > 1MM ortho surgical cases at 2 years after the end of surgery deferment. JBJS

Challenges when Restart in the UK

A report w/ the title of ”Getting the NHS back on track: planning for the next phase of COVID-19” was published in the UK by the NHS Confederation. The paper talks about the 7 challenges of the health care system when restarting the health care services in the UK.

Canaccord Sees Upside to H220

Canaccord feels SNN’s Q220 preliminary results suggest better-than-expected improvements and an upside to H220 estimates. Canaccord feels US states/health systems are better positioned to handle COVID cases and doesn’t expect widespread elective procedure restrictions.

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5 min read

International Medtech News Roundup: Updates from Around the Globe

By Thomas Wallick on 6/29/20 9:18 AM

As the international response to COVID-19 shifts to preparing for a potential second wave, the Medtech industry pushes forward with the development and approval of new devices. The following is just a small sampling of the past week's international updates that were curated, compiled, reviewed and posted throughout the day by the expert analysts at SmartTRAK. They sift through the noise to discover the latest international news, industry trends, financial data and competitor developments in the global Life Sciences industry.

Pandemic Reserve in Germany

In Germany, as a result of the past months, BVMed proposed to the Minister of Health to build stock for masks and protective equipment for 6 months to be used in pandemics.

How To Build Wound Care Knowledge

The Odense University Hospital in Denmark built up a blended learning concept in wound care for nurses to support them in gaining confidence when carrying out wound care. E-learning modules, study visits and workshops are mixed to address the needs.

Medical Device Promotion in France

In France, The National Agency for the Safety of Medicines and Health Products (ANSM) published a guideline on how advertising visas should be handled for medical devices during the state of emergency (until July 10, 2020) and through the year.

Restricted China Export Boost Local Market

Freight costs have increased dramatically during the COVID-19 outbreak. Chinese medical dressing export are mainly low cost, less advanced dressings. Manufacturers are now looking more to grow sales on their local China market, to replace imported more advanced dressings.

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6 min read

The Week in Neuromodulation: New Clinical Trials and Devices

By Thomas Wallick on 6/23/20 8:30 AM

This week, our expert analysts have sifted through the noise to present some of the latest product developments and clinical trials from the Neuromodulation industry. At SmartTRAK,  our analysts constantly monitor the worldwide MedTech industry to present real-time news, analysis and financial data. All of our analysts are experts in their field, having worked in business development, marketing and competitive intelligence roles at leading medical device companies.

The following is a small sampling of Neuromodulation segment updates from the past week that were compiled, reviewed and posted throughout the day by the industry-experienced analysts at SmartTRAK:

Mainstay Medical Receives FDA Approval for ReActiv8 System

Mainstay Medical rec’d FDA approval 6/16/20 for the ReActiv8 System indicated for stimulation of the L2 medial branch of the dorsal ramus for intractable CLBP assoc. w/ multifidus muscle dysfunction. Chris Gilligan, MD-INS Webinar: Novel Stimulation Technologies-Recent Research.

Non-Invasive VNS for PTSD and Mild TBI

The VA is sponsoring a 100-pt, double-blinded study evaluating the effect of non-invasive VNS (nVNS) vs sham on memory and symptoms of PTSD and mild TBI (mTBI) as well as brain and physiology in veterans w/ mTBI and PTSD. The study starts 8/1/2020. clinicaltrials.gov

Rice-Sized Neural Stimulator for DBS

Rice University researchers demonstrated that a miniature, wireless magnetically powered neural stimulator (> 100 Hz) can provide DBS in a rodent model for Parkinson’s disease and that these devices can be miniaturized to millimeter-scale and fully implanted. Neuron

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7 min read

The Week in Regenerative Medicine: Virtual Meetings, Studies and New Products

By Thomas Wallick on 6/16/20 6:30 AM

As states begin to loosen restrictions and we try and put COVID-19 in the rear view mirror, in the words of Bill Gates, "it's going to be a while before we can get back to normal" and companies are going to have to find creative ways to stay connected and engaged while moving forward and getting work done.

The following is a small sampling of Regenerative Medicine segment updates from the past week that were compiled, reviewed and posted in real-time by our SmartTRAK analysts, who are constantly monitoring the situation and sifting through the noise to present news, analysis, studies, trial results, patents and financial data that are most relevant to our subscribers.

TOBI 2020 Virtual Conference

For 2020, the TOBI Conference was held virtually due to COVID-19; still, attendance was fairly high. During one of the Virtual Lounge Q&A discussions, it appears that there is an emerging trend w/ some practitioners doing PRP inj then HA inj, not the other way around for knee.

Bone Therapeutics
BOTHE informed that in EU several clinical sites for JTA-004 Phase III trial have resumed recruitment as COVID-19 lockdown measures are lifted; 34 pts have been treated since the initiation of the trial mid-May 2020. Reporting of the topline results is currently planned for H221.

Detachable Hybrid Microneedle Depot for Localized Delivery of MSCs

This study presents a detachable hybrid microneedle depot (d‐HMND) for cell delivery The system deploys an array of "microneedles" w/ MSCs embedded in a gel-like matl, which prolongs cell viability & functionality, penetrating into a target tissue w/ high spatial precision. ADFM

PRP Formulations and Uses

US Patent Application “PLATELET RICH PLASMA FORMULATIONS AND USE THEREOF” was published, relating to compositions for PRP depleted in neutrophils to treat damaged connective tissue &/or slow/stop cardiac apoptosis after a heart attack, along w/ reperfusion therapy. 20200179455

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4 min read

Meet Joe Mish - Director of Sales

By Thomas Wallick on 6/11/20 4:19 PM


We are pleased to announce that Joe Mish has joined the team at SmartTRAK as Director of Sales. Joe has 10+ years experience in medical device sales, with concentration on Joint Replacement and Spine & Robotic Technologies. Prior to joining SmartTRAK, Joe sold and implemented analytic software to manage value-based care and bundled payment, working with Stryker, LDR/ZimmerBiomet and Stryker Performance Solutions.

Meet Joe Mish:

What is your role with SmartTRAK? I will be joining the commercial team as Director of Sales.

What do you like about SmartTRAK? I’ll give you two perspectives here. First, with regards to the technology, I love the value proposition to our current and prospective customers. With the world being so volatile and business being severely disrupted (especially for surgery and device companies) being able to offer a solution to reduce risk, improve profitability and productivity makes this a fantastic time to partner with organization’s and build strong, long-lasting relationships. This was truly a deciding factor in making a career/company change. Second, with regards to the company, I love the people. Coming from multiple large Fortune 500 companies with very specific cultures, individuals and team comradery is often and easily overlooked. I have been so impressed with the professionalism, transparency and family vibe from every person I have engaged with and I have only been on board for a week! This feels like a very special group of incredibly talented people and I am honored to be a part of it.

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6 min read

The Week in Wound Care: New Studies, Products and COVID-19 Impacts

By Thomas Wallick on 6/8/20 7:37 PM

As the world begins to reopen from COVID-19, the wound care industry is making progress on new medical devices and studies. The following is a small sampling of Wound Care segment updates from the past week that were compiled, reviewed and posted in real-time by our SmartTRAK analysts, who are constantly monitoring the situation and sifting through the noise to present the most relevant news to our subscribers.
 
Alliance of Wound Care Stakeholders - CMS COVID-19 
  • The Alliance of Wound Care Stakeholders requested that CMS allow HOPDs and MDs to bill for furnishing dNPWT during the COVID-19 pandemic when providing wound assessment and instruction to patients in their home on the application of dNPWT via telehealth.
  • The Alliance of Wound Care Stakeholders submitted comments to CMS COVID-19 Public Health Emergency Interim Final Rule. The Alliance supported the Agency’s implementation of many policies while also pursuing clarification on several specific provisions.
Pressure Injury in China

A study of 1,806 nurses from 10 hospitals in China on nurses' knowledge, attitudes and behaviors for promoting PI-prevention found 41.7% had insufficient PI-prevention knowledge, 46.6% had negative PI-prevention attitudes, and 21.8% had poor PI-prevention behavior. J Clin Nurs

Improved Textured Breast Implants

Establishment Labs’ US Patent Application “TEXTURED SURFACES FOR BREAST IMPLANTS” was published, describing irregularly-textured breast implants with significantly improved cellular response over current textured implants. 20200170771

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4 min read

This Week in Ortho: Projecting the Market's COVID-19 Recovery

By Thomas Wallick on 6/1/20 6:53 PM

As access to healthcare continues to open up, the orthopedic industry is taking significant precautions to insure the health, safety and piece of mind of patients and caregivers and balance that with its attempt to ramp up services and procedures. The following is a small sampling of the orthopedic updates compiled, reviewed and posted in real-time by our SmartTRAK analysts, who are constantly monitoring the situation and sifting through the noise to present the most relevant news to our subscribers:

Updated Survey Data Points to Recovery by Q420

WFS’ new survey of 623 US-based physicians (15 specialties) shows that in orthopedic, the % of procedures expected to be postponed due to COVID-19 for both TKR and THR declined from 94% (Wave 1) to 85% (Wave 2). WFS MedTec: Updated Survey Data Points to Recovery by Q420

Impact of COVID-19 on the Spine Market

Of deferred spinal fusion procedures, surveyed surgeons now expect 74% of cases to be performed at a later date w/ 26% cancelling. Reasons for cancellation include pt seeking treatment w/ a different surgeon (26%) and underlying condition improving (23%). WFS MedTech Survey

Robotic Procedures Affected by COVID-19

Based on its survey of 623 US-based physicians across 15 specialties between April 27 and May 8, WFS notes that in general the % of robotic & laparoscopic procedures across all specialties declined compared to pre-COVID 19 levels, while the % of open procedures increased.

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7 min read

COVID-19: Vaccines, Testing and the Future for MedTech

By Thomas Wallick on 5/26/20 8:00 AM

With social distancing and travel restrictions easing worldwide, and WHO warning of a possible second peak of the pandemic, the work continues on potential vaccines to prevent COVID-19 and treatments for those already affected by the virus. The following is a small sampling of the COVID-19 updates compiled, reviewed and posted in real-time by our SmartTRAK analysts, who are constantly monitoring the situation and sifting through the noise to present the most relevant news to our subscribers:

Remdesivir Shortens Recovery Times in COVID-19 

Preliminary results of a double-blind, randomized, placebo-controlled trial of IV remdesivier in adults hospitalized w/ COVID-19 and lower respiratory tract infection showed remdesivir was superior to placebo in shortening recovery times (11 days vs 15 days; p=0.001). NEJM

Orthopedic Surgery During COVID-19

This JBJS article discusses medically necessary orthopaedic surgery during the COVID-19 pandemic and recommends safe surgical practices and a classification to guide tx. JBJS

US Plans Massive COVID-19 Testing Effort to Deliver Vaccine by YE20

The US plans a massive testing effort involving more than 100K volunteers and ~6 of the most promising vaccine candidates in an effort to deliver a safe and effective one by YE20, compressing what is typically 10 yrs of vaccine development/testing into a matter of months. Reuters

COVID-19: Vaccine Shows Promise in Early Trial

Moderna reports preliminary data suggests its COVID-19 vaccine is safe and appears to be eliciting an immune response in test subjects. The FDA has given the Company approval to begin a Phase II study w/ ~600 volunteers. A Phase III study may begin by July. NPR

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7 min read

COVID-19: Restrictions Ease as Vaccine Development Ramps Up

By Thomas Wallick on 5/18/20 3:29 PM

As restrictions begin to ease around the world, the Life Sciences industry prepares to deal with the impending ramifications. While progress is being made on vaccines and treatments as new surgery guidelines are developed, the potential long term consequences of the pandemic must be addressed. The following is a small sampling of the COVID-19 updates compiled, reviewed and posted in real-time by our SmartTRAK analysts, who are constantly monitoring the situation and sifting through the noise to present the most relevant news to our subscribers:

COVID-19: WFS Call on Reopening America

During a Wells Fargo call, Dr. Ashish Jah, Dir of Harvard Global Health Institute, projected the US economy will ramp up to 80% open by fall w/ an increase of elective procedures in the summer to 100% or higher. He doesn’t anticipate a fall return of COVID halting procedures.

Impact of COVID-19 on Spine Procedures

Based on conversations with healthcare and industry professionals, SmartTRAK expects deferred spine procedures to reschedule more quickly than many other procedures due to the non-elective nature of spine cases – particularly those w/ neurological deficit or progressive pain.

Pfizer's COVID-19 Vaccine in Human Trials

Pfizer working alongside German drugmaker BioNTech injected its potential COVID-19 vaccine in first human participants last week and hopes to test up to 360 people in its clinical trial. If the vaccine is found safe and efficacious it could be available starting in Oct. CNBC.com

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6 min read

COVID-19 Updates: MedTech Fights Back

By Thomas Wallick on 5/11/20 8:57 PM

While some countries are slowly emerging from their lockdowns, the MedTech industry continues to face unprecedented challenges as it adapts to the changing landscape. SmartTRAK's analysts are constantly monitoring the effect COVID-19 is having on the Life Sciences industry, sifting through the noise to present the most relevant news to its subscribers. Our analysts continue to publish real-time updates throughout the day, detailing what you need to know about the impact the international healthcare crisis is having on the industry at large.

Following is a selection of the COVID-19 updates from the past week as compiled by the analysts at SmartTRAK:

COVID-19: Advamed Issues New Code of Ethics Guidance

Advamed announced the availability of its new “Code of Ethics Compliance Guidance Related to the COVID-19 Response” to help its members and other MedTech companies develop and implement processes supporting rapid decision making and mitigate any related compliance risks.

MedTech Europe 

MedTech Europe, the European trade association representing the medical technology industries, issued a statement around COVID-19 calling attention to the supply situation of medical devices. They also highlighted that some contracts need to be revised and analyzed.

COVID-19: FDA Removes Respirators Manufactured in China

In a letter to healthcare providers, the FDA announced it removed a number of EAU disposable filtering facepiece respirators manufactured in China. The products pulled failed to demonstrate a minimum particulate filtration efficiency of 95% in testing conducted at NIOSH. fda.gov

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