Med Device Monday: Breakthrough Device VectRx by NeoTherma Oncology

How is it October already? Soon it’ll be November and time to VOTE (don’t forget!)

Every year since we started the AcKnowledge RS blog, we’ve dedicated a month to medical devices that have not yet received FDA approval. It’s an easy way to see what cool things people are inventing, and maybe give you a small glimpse into the future. Who knows, you might be able to “ask your doctor whether Device XYZ is right for you” in the next few years!

The next device in our series is called VectRx™, a Thermal Treatment (TTx) system being developed as an adjunct therapy for solid tumors. This device comes from Kansas-based device maker, NeoTherma Oncology, and has been granted FDA breakthrough device designation for treatment of pancreatic cancer. The company prides itself in providing a “more effective and more humane solution for treating cancer.”

From the www.neothermaoncology.com website:

“Our technology is based on applying a safe, non-invasive, nonionizing electromagnetic field to produce local ‘fever-range’ temperatures in tumor tissue, intended to increase the effectiveness of anticancer radiotherapy, chemotherapy and immunotherapy. The energy emitted by our TTx device increases blood perfusion in tumor micro-environment, reversing the treatment-resistant hypoxia, and promoting a therapeutic immune response.”

Hold up…let’s back up a minute and talk about cancer…chances are, you or someone you know has been directly affected by this disease. According to the American Cancer Society’s recent report, in 2018 alone there will be an estimated 1,735,350 new cancer cases diagnosed and 609,640 cancer deaths in the United States. This disease is defined as the uncontrolled division of cells in the body. Many cancers form solid tumors, which are abnormal masses of tissue, and can either be benign (non-cancerous) or malignant (cancerous). Solid tumors are named for the type of cells that form them, and include sarcomas, carcinomas, and lymphomas. Treatment for solid tumors is generally a combination of surgery, chemotherapy and radiation therapy.

Pancreatic cancer — statistically known as the deadliest of the solid tumors — is the fourth leading cause of cancer-related death in both men and women. The NIH based National Cancer Institute estimates that 55,440 new cases of pancreatic cancer will be diagnosed and 44,330 deaths will be associated with the disease this year. Last year there was an estimated 43,090 deaths caused by this type of cancer and researchers place the 5-year relative survival rate at a meager 8.5%. Radiation therapy and chemotherapy are currently the main treatment options for pancreatic cancer. Unfortunately, less than 20% of patients are candidates for surgery because pancreatic cancer is often detected well after it has spread beyond the pancreas. Enhancing the efficacy of existing therapies is one crucial way that scientists and doctors can improve treatments for this deadly cancer. With all these stats in mind, it’s not hard to see why FDA designated this product as a Breakthrough Device. It clearly meets the first criterion that states it “provide a more effective treatment for a life-threatening or irreversibly debilitating human disease” [emphasis added].

Cancer.MagnifyingGlass

As mentioned above, the VectRx device provides a radio frequency thermal treatment to raise the temperature around the tumor from 37°C to ~42°C. This localized increase in temperature at the tumor site can support the chemotherapy treatment by increasing the blood flow around the tumor (thus enabling the drugs to penetrate the tumor at lower doses). Warming up the tumor site also likely provokes a therapeutic immune response by increasing the tumor cell surface proteins. Helping make the chemotherapy drugs more efficacious while making you feel less cruddy, along with triggering the body’s natural defense system to attack the tumor, equates to a serious ‘one-two punch’ combination in this fight against cancer! It’s exciting to know that VectRx works at increasing the efficiency of the available treatments, while simultaneously minimizing the harsh effects that those treatments have. The device is being developed for treatment of a wide range of cancers, but the lead target for the company right now is pancreatic adenocarcinoma.

Although surgery, radiation therapy, and standard chemotherapy will continue to play an important role in treating cancer, the emergence of novel adjunct therapies like VectRx will expand the treatment options available to cancer patients. We’re excited to see how FDA and NeoTherma Oncology work together to bring this potentially game-changing treatment to the US market.

Additional Reading:

1.       More info about NeoTherma Oncology

2.      Press Release about VectRx’s Breakthrough Designation

3.      More info about Pancreatic Cancer from NIH National Cancer Institute

4.     NeoTherma Oncology secures grant from National Cancer Institute

MDMonday: NERV Technology's Implantable Biosensors

How is it October already? Soon it’ll be November and time to VOTE (don’t forget!)

Every year since we started the AcKnowledge RS blog, we’ve dedicated a month to medical devices that have not yet received FDA approval. It’s an easy way to see what cool things people are inventing, and maybe give you a small glimpse into the future. Who knows, you might be able to “ask your doctor whether Device XYZ is right for you” in the next few years!

This week we’re focusing on an implantable biochip by a company called NERv Technology Inc. This bioresorbable chip aims to help detect postsurgical complications by identifying internal bleeding, leakage of bodily fluids, and infection within the abdominal cavity. As described at the ne-rv.com website:

“NERv’s biosensors are predictive. They collect data and identify a specific kind of complication as soon as it develops. The biosensors provide information before the complication reaches a critical stage. NERv’s biosensors provide a preventative approach to post-operative care by identifying a complication as it is developing and preventing the development of further complications.”

A medical device that might be able to predict the future in order to prevent critical post-operative complications!? Someone call Tom Cruise and let him know Minority Report needs a remake!

Postsurgical Complications

Over 7,000 individuals die every year due to the failure or late detection of post-operative complications. Postsurgical or post-operative complications can result from the operation itself or other unrelated factors. Post-operative complications cause longer hospital stays and increased healthcare costs, not to mention the suffering that many patients (and their families) may go through. While it depends on the surgery, some common complications include pneumonia, internal bleeding, deep vein thrombosis, infection, and pulmonary embolism. The clinical signs of disease are often blurred in the postoperative period. Early detection of postoperative complications requires repeated evaluation of the patient by the operating surgeon and other team members, which can be time consuming and laborious for everyone involved. Additionally, some of these complications take days or weeks to show up, often well after you’ve gone home to recover. The current methods for detecting post-operative complications include imaging techniques like CT and MRI scans, as well as lab tests which are only performed once the patient has demonstrated certain symptoms…and these all of course take you out of your comfy recovery chair at home and bring you back to the hospital. Which is good if you do need to go to the hospital, and not-so-good if it turns out to be an unnecessary visit.

 Screenshot from www.ne-rv.com/

Screenshot from www.ne-rv.com/

How does the device work?

The NERv biochip is about the size of a shirt button, and is implanted into the body during surgery. As soon as a complication develops post-surgically, the chip is able to detect it and collect information about its status. The data are sent to a receiver located in a trans-dermal patch placed on the wound after surgery. While the patient may receive a simple alert notification so that they are able to seek medical care right away, the physician will get a more detailed analysis of the patient’s status. The biosensors in the chip have demonstrated to be very sensitive; able to detect even small changes of specific biomarkers associated with these complications. Physicians will also be able to get information on the kind, location, and severity of the complication. Made of bioresorbable materials, the biochip sticks around for a month before it is broken down by the patient’s body, thus avoiding another surgery to have it removed.

We’re excited to see medical devices like this being developed! We look forward to keeping tabs on NERv…and watching this technology get to market and safely into patients!

Additional Information:

1. NervTech Website

2. NERv Illustration Animation

Med Device Monday: Help for Dry Eyes by AesculaTech

How is it October already? Soon it’ll be November and time to VOTE (don’t forget!)

Every year since we started the AcKnowledge RS blog, we’ve dedicated a month to medical devices that have not yet received FDA approval. It’s an easy way to see what cool things people are inventing, and maybe give you a small glimpse into the future. Who knows, you might be able to “ask your doctor whether Device XYZ is right for you” in the next few years!

We start this month with AesculaTech, named after Asclepius, the Greek god of healing. This LA-based biomedical startup is developing a thermally responsive hydrogel for treatment of dry eye syndrome. Dry eye syndrome is pretty much what it sounds like: a prolonged absence of adequate lubrication and moisture on the surface of the eye. Symptoms of dry eye include constant eye irritation, stinging, burning or scratchy sensation in the eyes, sensitivity to light, redness and blurred vision or eye fatigue. There are a host of factors that increase your risk of having dry eyes, including prolonged computer use, frequent flying, birth control pills, smoking, contact lens wear, diabetes, arthritis, antihistamines, allergies, and aging. So pretty much “living” can lead to dry eye! A 2012 Gallup poll showed that more than 26 million Americans suffer from dry eyes, and this number is expected to increase to more than 29 million within 10 years.

There are prescription medications as well as over-the-counter (OTC) eye drops currently used for the treatment of dry eye syndrome. Unfortunately, many prescription medications need to be used for a long time before any improvement in the condition is evident, and OTC eye drops (artificial tears) only bring temporary relief and require frequent reapplication.

AesculaTech’s propriety material, the AesculaGel, is unique in that it can achieve three different states of matter. AesculaTech co-founder and chief science officer Niki Bayat refers to the AesculaTech Gel as “Reverse Chocolate” as at low temperatures, the AesculaGel is a liquid. However, as it warms up it turns into a gel, only reaching solid state when it hits body temperature.

eye.closeup

To simplify, the liquefied AesculaGel is injected by your doctor into your tear duct which then solidifies as it reaches body temperature. A tiny plug forms that prevents tears from draining away from the surface of the eye. This procedure is intended to be performed during a quick, in-office procedure and last for about a year.

Pre-clinical animal trials using AesculaGel have shown statistically significant increases in tears in the eyes. The company is now preparing for human clinical trials before a pre-market submission to FDA.

According to Aesculatech, AesculaGel is initially being tested for the treatment of dry eye syndrome but there are plans to use the gel for the treatment of glaucoma. According to Bayat and co-founder Andrew Bartynski, AesculaGel has a wide range of potential applications, including pharmaceuticals, medical devices, cosmetics, and textiles. Moreover, since AesculaGel could be used for sustained, localized drug delivery therapies, patient non-compliance to drug regimens to treat chronic conditions could also be potentially addressed.

Additional Reading:

1.       More info about AesculaTech

2.       Future plans for the AesculaGel for drug delivery

3.       More info from NIH about Dry Eye

Med Device Monday: BONEBRIDGE by Med-El

Hearing loss is the third most common health problem in the U.S after heart disease and arthritis. It is estimated that about 48 million Americans have some form of hearing loss, often caused by illness, genetics, or other ear-damaging elements that come with a modern lifestyle (e.g. sporting events, airplanes, concerts, and working with heavy machinery). FDA recently granted a de novo request for the BONEBRIDGE device, manufactured by Austrian company, Med-El. BONEBRIDGE is an active bone conduction implant system, and is designed for individuals 12 years and older who have conductive hearing loss, mixed hearing loss, or single-sided deafness.

To understand who should use this device, we need to understand a little more about the types of hearing loss. Hearing loss can be categorized into 4 categories:

  • Conductive: Any problem in the outer or middle ear that prevents sound from being conducted properly.

  • Sensorineural: Hearing loss that results from missing or damaged sensory cells (hair cells) in the cochlea and is usually permanent.

  • Mixed: As the name suggests— is a combination of conductive and sensorineural hearing loss, indicating damage in both the outer or middle ear, and the inner ear.

  • Neural: Neural hearing loss results from the lack of or damage to the auditory nerve, which is a bundle of fibers that carries auditory sensory information from the cochlea to the brain.


Traditional cochlear implants help patients who have sensorineural hearing loss as they replace the functional components of the inner ear (read more about cochlear implants on our blog from May 2016)! Alternatively, BONEBRIDGE is indicated for conductive or mixed hearing loss, which means sound cannot take the natural route through the outer and middle ear to the inner ear. This makes it difficult for the hearing loss sufferer to hear soft sounds and can also lead to the muffling of louder sounds.

 Image from www.medel.com/us/bonebridge

Image from www.medel.com/us/bonebridge


BONEBRIDGE transmits sound waves via bone conduction directly to the inner ear, where they are processed as natural sound. The device consists of two components: an externally worn audio processor (called SAMBA), and a surgically-inserted bone conduction implant (called the BCI 601) which lies directly beneath the skin. The audio processor is held directly above the implant using magnetic forces.

Now, let’s get into the specifics of how this device works! Initially, the microphones of the audio processor pick up the sound waves. Then, the audio processor converts those sound waves into electrical signals, which are then transmitted through the skin to the implant. The implant, which is fixed in the temporal bone, converts these electrical signals into mechanical vibrations which are transmitted to the skull. The bone then conducts these vibrations to the inner ear. Signal transmission to the inner ear via bone conduction bypasses the outer and the middle ear, solving the complication of sound’s inability to pass through the natural route that comes with conductive and mixed hearing loss. The inner ear then processes these mechanical vibrations in a way that is similar to the way natural hearing is processed, and transmits nerve signals to the auditory nerve in the brain.

The audio processor is equipped with adaptive directional microphones, which adapts to different environments and individual usage. One of the really cool things about the audio processor (not that the device isn’t already super cool) is that it automatically identifies and minimizes noise interference in situations where there is loud background noise, which can become overwhelming to people who aren’t used to those background noises. The audio processor also comes with a remote control that has wireless connectivity capabilities. Using this remote control, the users can select different programs that have various settings depending on the user’s current environment or activity.

FDA classified BONEBRIDGE under product code PFO as a Class II device with special controls. These special controls include:

1.       Clinical performance testing

2.       Non-clinical performance testing (includes impact testing, mechanical Integrity testing, etc.)

3.       Biocompatibility testing

4.       Sterility of the patient-contacting components of the device

5.       Shelf life of the device

6.       Wireless compatibility, electromagnetic compatibility, and electrical safety

7.       Software verification, validation, and hazard analysis

8.       Labeling

 

We’re so excited to see medical technology like this enter the US market!

Additional Reading:

1.       FDA Classification Order

2.       Video explaining how the BONEBRIDGE works

3.       More info about BONEBRIDGE

4.       More info about the de novo process HERE and HERE

FDA Friday: Updates to our Previous De Novo Pathway Blog

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A little over two years ago, in one of our earlier blog posts, we discussed the de novo pathway. Since then, while the fundamentals of the program have remained the same, several changes have occurred to this pathway in terms of user fees and review time. We’d like to bring you up to speed on some of the changes in this blog post.

Briefly, the de novo pathway (as mentioned in our previous blog post) is an alternate pathway added through the Food and Drug Administration Modernization Act of 1997 (FDAMA). This pathway was added in order to classify novel, low- to moderate-risk Class I and Class II medical devices that did not have an acceptable predicate device (in order to establish substantial equivalence via the 510(k) pathway), and had not already been classified as Class III (“high-risk” devices).

There are still two routes for a de novo classification:

1.       Submitting a de novo request to the FDA after an NSE determination in response to a 510(k) submission.

or,

2.        If there is no legally marketed device upon which to base a determination of substantial equivalence, the sponsor may submit a de novo request without first submitting a 510(k) and receiving an NSE determination.

 

Such devices cleared through the de novo pathway may be used as predicates for future 510(k) submissions. Though not required, FDA strongly recommends a Pre-Submission in order to obtain early feedback from FDA, saving the submitting company both time and money. A Pre-Submission will not only help sponsors obtain feedback on whether a device may be eligible for the  de novo classification process, but also feedback on any on non-clinical and/or clinical data that will likely be necessary to support the de novo request.

In terms of the submittal, the de novo application should be submitted as an e-copy to the appropriate Document Control Center in CDRH or CBER. FDA’s goal is make a decision on the de novo request in 150 days. Since 2010, FDA has been releasing summaries of the devices cleared through the de novo process which will help sponsors that may wish to use the device as a predicate for future 510(k) submissions. Starting on October 1, 2017, changes were made to the user fees that are as follows: FDA now charges a fee for review of the de novo application unless you qualify for one of the exceptions:

1.        The device being submitted is a device intended solely for a pediatric population

or,

2.       Any application from a state or federal government entity

 

In 2017, FDA also released guidance documents on the de novo Classification Process and User Fees and Refunds for de novo Classification Requests.  De novo may be a faster pathway for you to get your novel, low- to moderate- risk devices to the market. Ask your regulatory consultant if a de novo is right for you!

 

Additional Reading (Guidance Documents):

1.        Our Previous Blog about De Novos

2.        De Novo Classification Process

3.       User Fees and Refunds for De Novo Classification Requests

4.       FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals

5.       Acceptance Review for De Novo Classification Requests