In The News …
IDS Successfully Completes Phase 3 Clinical Trials
January 15, 2018
The company is pleased to announce the results of BreasTel’s Phase 3 Clinical Trials conducted during late 2016 to late 2017. These clinical trials involved 200 patients who presented themselves to the Radboud Medical Centre in Nijmegen, Holland as having a significant “lump” in their breasts. The testing was conducted by the patients and overseen by the clinical staff and doctors at the Medical Centre.
After significant medical and statistical analysis involving “Specificity” and “Sensitivity,” the overall “Accuracy” of BreasTel was found to be 97.2%. The company is pleased with these results and intends to finish the development of the BreasTel device working with a major manufacturer.
As a consequence, the company has filed for an additional patent on the artificial intelligence deep neural network algorithms that power the results. The company already has three granted patents and with the latest application will have four, plus a worldwide trademark (including the European Union) on the name “BreasTel.”
IDS Begins Phase 3 Clinical Trials
July 28, 2016
Upon successful conclusion of its Phase 2 Clinical Trials, the company is pleased to announce the beginning of Phase 3 Clinical Trials in Holland. The company has entered into a contract with the Radboud University Medical Centre located in Nijmegen, Holland to test up to 200 women with breast abnormalities and has started work on this activity. This facility is one of the largest breast care centers in The Netherlands.
The Radboud University Medical Centre has been in existence since 1956 and works with regional, national, and international partners. The Medical Centre employs 10,341 employees and offers educational services to 2,216 medical students, 552 medical bioscience students and 443 dentistry students. Special units include neurosurgery, cardiothoracic surgery, and breast care among other servicers.
MediReva – Letter of Intent and Investment
February 13, 2016
The company has signed a Letter of Intent (LOI) with the MediReva Group of companies (www.medireva.com). MediReva is a $150 MM company based in Maastricht, Holland and consists of a group of nine specialty enterprises that service the healthcare industry, including breast care. Among other things, the LOI offers our company the Right of First Refusal for exclusive rights of sales and distribution of BreasTel in the Benelux Region of Europe, which encompasses Holland, Belgium, and Luxembourg. In exchange, MediReva has made a substantial investment in the company. The company will begin negotiations on this agreement when the BreasTel product becomes available for commercial release. We are extremely pleased to develop this type of relationship with a major corporation and plan to develop more in the future.
IDS Announces Completion of Phase 2 and Start of Phase 3 Testing
December 15, 2015
The company today announced that they have successfully completed their Phase 2 Clinical Trials. The Clinical Trials were conducted at the Harbor-UCLA Medical Center in Los Angeles. The company now has enough data to move on to the Phase 3 Clinical Trials.
During Phase 2, the company received a total of about 2,280 data files, 760 individual ultrasound observations of either full spectrum (full color) or grayscale (1 color) images and have computed 760 time-amplitude echographs from women with suspicious lumps being either malignant or benign abnormalities. The results met our medical expectations and have resulted in direct confirmation that the ultrasound probe is working properly, reading properly, and reporting all the correct and accurate results expected. The protocols were very clear and the decryption worked perfectly. The vector data was in range and the images very clearly showed the presence or absence of an abnormality in the breast.
IDS Announces New CEO: Deborah Goslin
July 13, 2015
IDS is proud to announce the appointment of Deborah Goslin as Chief Executive Officer and Director – Board of Directors, effective September 1, 2015.
For the last four years Kenneth J. Purfey has been the Chief Financial Officer and Acting Chief Executive Officer of the company. Mr. Purfey states that “our company has been expanding rapidly over the last few years. The reason I have been an ‘Acting CEO’ all this time is because we have been waiting to find a highly qualified female with a Bio-Science background to take the helm. I am very proud to say that we have found one. With Deb Goslin’s help we can prepare to take the company to the next level.” Mr. Purfey will retain the position of Co-Founder and CFO, and help Mrs. Goslin transition up to and well beyond our next milestones.
Mrs. Goslin has a solid track record of high-value fundraising from venture and strategic capital markets, and has a global reputation for superior ROI for investors via premium exits. She knows the importance of overcoming barriers-to-entry against competition through innovative product planning, execution, and IP protection. With over 37 years of experience, she has held the positions of Executive Chairman of Health SaaS.net, Chairman & CEO of BD Guidance Corp, CEO of Wanda Inc., CEO of Encirq Corp, CEO & President of SPV, EVP of Global Sales for Adaptive Insights, EVP Sales of NetBrowser, EVP of Platinum Technology, VP Sales of Comdisco, VP Sales of Metaphor Systems, Director of Sales for Siemens Inc., and Executive Director at the University of Miami, Miller School of Medicine.
Her education includes a Bachelor of Science, Nursing from Florida State University, a Master’s Degree from the University of Miami Miller School of Medicine, and an Executive MBA from Duke University, Fuqua School of Business.
IDS Hires CE Mark and FDA Consultant
June 26, 2015
IDS announces the engagement of Mr. Craig Coombs as a Consultant to manage the company’s overall CE Mark and FDA processes for approval of our BreasTel device. Mr. Coombs has been the President of Coombs Medical Device Consulting (CMDC) since 2000. His company specializes in hands-on, innovative U.S., European, and Asian regulatory strategies for start-ups and companies that need to improve or enhance their strategies. CMDC skills include cost-effective First-In-Human or VC milestone clinical trial design, management, and analysis. During his twenty-three years of medical device regulatory work which includes FDA and CE Mark approvals, he has been a Vice President of Medtronic in the areas of Regulatory Affairs, Quality Assurance and Clinical Studies. Mr. Coombs received his B.S. (Biology) from Stanford University. Mr. Coombs is also on the Adjunct Faculty for the University of California (Santa Cruz) in Medical Device Submissions. The company is pleased to welcome him, and he will be working with Dr. Tim Stein on compliance and regulatory issues.
IDS Represented at Amsterdam Innovation Summit
June 24, 2015
IDS was represented at the recent “Next 100 Women Innovation Summit” in Amsterdam, Holland. This Summit was sponsored by the Female Cancer Foundation, a group consisting of some of the most powerful women in The Netherlands. The company had a BreasTel exhibit that was visited by dozens of attendees and most took the company’s handouts.
The company’s representative said, “The interest in BreasTel is huge and they are all very positive about the innovation and possibilities—most women said they will purchase it once available. The event did offer a great platform to present BreasTel and I foresee, on top of the other marketing and sales efforts, a great direct sales opportunity to attend these kind of events in the future after the market introduction.” Accordingly, steps have been taken to follow up with interested parties.Market Opportunity for BreasTel in the U.S. and E.U.
(Research Report by Meredith Huntley & Scott Huntley)
June 10, 2015
In April 2015, a special research study was conducted on behalf of IDS to determine the market for a device that would enhance the ability of a woman to perform a Breast Self Exam (BSE) and aid in the detection of abnormalities. Hundreds of women in both the U.S. and E.U. were questioned about a variety of BSE topics.
A majority of the women (about 80%) owned a smart phone, a component necessary to the device, and about the same percentage reported that they perform a BSE at least once a year, with 34% reporting that they perform a BSE at least monthly. Most women (70%) have a doctor that they see for regular checkups, and 90% said they would see a doctor if they felt a suspicious lump. Interestingly, the other 10% said they would not want to know if the lump was suspicious. This latter fact indicates that additional education is needed for some women in the prevention and detection of potentially dangerous abnormalities.
At least one-third of the women said they would pay $99 for such a device, while 70% said they would recommend such a device to their friends or family. When extrapolated to the eligible population of women in the U.S. and E.U.—using a target age of over 40—this represents a total market opportunity of $2.3 Billion domestically and nearly $4 Billion in the E.U., for a total market of $6.3 Billion. From a population perspective, this market represents at least 23 million women in the U.S. and 37 million women in the E.U, for a total market of 60 million women.
IDS Hires Regulatory Consultant
May 28, 2015
Identification Solutions has engaged Dr. Timothy Stein as a Regulatory Consultant to help guide the company initially through the CE Mark (Europe) regulatory process and later through the FDA (USA) regulatory process. For the last 20 years, Dr. Stein has been the owner of Business Performance Associates Inc., a firm located in Cupertino, CA and has guided over 110 clients through the CE Mark/FDA processes since then. His firm will help provide IDS with software design development processes that are compliant with IEC 62304:2006, design control requirements (QSRs and ISO 13485); FDA guidance documents for submission, preparation of documentation for 510(k) submission for products that include software, and testing of medical device software. His goal is to help IDS achieve software regulatory compliance.
April 1, 2015
To the best of our knowledge, Identification Solutions is the first company in the world to get an Android phone to respond to an ultrasound signature! This is an amazing engineering breakthrough because smart phones were never intended, nor designed, to work with ultrasound. Yet we have done it. We have a working prototype of the BreasTel unit that works with extremely high accuracy on phantom breasts when attached to an Android phone.
BreasTel Clinical Trials – Mammoth Hospital and Medical Center – completed
IDS successfully completed our Phase 1 Clinical Trials at Mammoth Hospital and obtained 62 ultrasound signatures as preliminary indication of proof of principle. These trials convinced us we were on the right track.
BreasTel Clinical Trials – UCLA Medical Center – underway
The company started our Phase 2 Clinical Trials at the UCLA Medical Center-Harborside, David Geffen School of Medicine, in Los Angeles, CA in mid-2014. These trials which are testing 100 women with likely breast cancer are intended to locate, identify, and characterize breast abnormalities as either potentially harmful or not harmful. The information gathered from these trials is improving the accuracy of our algorithms as well as creating a “never-been-done-before” data library of ultrasound signatures of malignant breast tumors. This sort of critical health information could be very valuable to larger health care companies.
To date, the results have met our medical expectations and have resulted in direct confirmation that the ultrasound probe we are using is working properly, reading properly, and reporting all the correct and accurate results that we expected. The protocols were very clear and the decryption worked perfectly. The vector data was in range and the PC images very clearly show the presence or absence of an abnormality in the breast.
We intend to begin our Phase 3 Clinical Trials as soon as we complete Phase 2. Phase 3 Clinical Trials will test 100-300 women with known breast cancer to further improve our algorithms as ready for commercialization and BreasTel sales, continue and refine our data collection techniques and analysis, and expand our intellectual property library of malignant tumor ultrasound signatures.
We also intend to publish a white paper research report to the Medical Community.
DIY Health News
Rise in Virtual Health Tools: Saving $10 Billion in Primary Care
October 29, 2015
The good news from a recent Accenture Consulting report is that virtual health care—in the form of digital tools—can lower patients and insurers costs, and save physicans valuable time, to the tune of up to $10 billion.
With an expected shortage of primary care physicians, digital tools, including biometric devices, analytic diagnostic engines and virtual medical assistants, may be the answer. According to the report, “By shifting some work to patients, replacing labor with technology, and automating taskes, virtual health can streamline clinician work, decrease demand for primary care providers and focus clinician time in areas where their training and experience have the greatest value.”
The need for these virtual tools was a result of physician’s facing an ever-burgeoning patient load and the desire to locate cost-reducing strategies across the board. While face-to-face visits and most medical testing will still be required, some of the upfront work can be done at home, by the patient themselves, and uploading the data to a physician’s secure portal.
From filling out forms, answering simple intake questions and detailing medical history to uploading biometric information from wearable sensors, digital scales, and simple devices like a blood pressure monitor or blood sugar test strips, patients can provide information to a doctor before ever stepping into an office. They can thoughtfully fill out forms and upload data at their leisure, rather than in a waiting room or rushed appointment. And doctors can review these items before ever seeing the patient, allowing them to craft a plan of action and seek additional information as needed.
In some cases, eVisits can replace actual in-person doctor visits, another bonus of virtual health monitoring. These work particularly well with patients who have chronic illnesses such as diabetes, hypertension, and heart conditions.
The report states that the ratio of virtual to in-person care will shift over time as technologies evolve, and possibly allow for better continuity of care for patients. And in the long run this will save an inordinate amount of money.
Mobile Health & Monitoring Predicted to Rise
April 13, 2015
A recent report by Mobile Future Forward provided a glimpse into the DIY Health Care sector’s future. Titled “2015 Mobile Industry Predictions Survey,” this report is the eighth in an annual series that polls insiders to get a look into what “the ecosystem is thinking about the future.”
Of note was the impressive statistics on growth overall in the first half of this decade: 483% growth in digital information, 12,816% growth in mobile data traffic, 339% growth in smartphone sales, 1,344% growth in tablets sales, 73% growth in data revenues, 433% growth in OTT revenues, 50% growth in mobile industry revenues, and 341% growth in mobile apps revenue. All this bodes well for those in the mobile health industry, particularly the statistics on consumer mobile applications, which shows Mobile Health and Wellness anticipating a 50% increase during 2015.
Another section of the report address the issue of the sectors that will be most impacted by mobile in the next five years. The clear winner in this category was Health & Monitoring, which is anticipated to have a 60% growth over the next half decade.
Identification Solutions, Inc. is developing products for the mobile health and wellness sectors, with BSE Aware and the handheld BreasTel consumer product, both of which utilize smartphones and apps.
Breast Cancer News
Text Message Alerts Increase Breast Cancer Screenings
April 6, 2015
In a recent study by the Imperial College Healthcare Charity in the U.K., researchers found that women who are sent a text alert reminder for breast screening appointments are more likely to keep these important appointments.
The study, published by the British Journal of Cancer, tracked 835 women who were asked to attend their first ever breast screening exam. Text message reminders were sent to 450 of these women, 72% of which kept their appointment. Of those who did not receive a text message, only 60% made it to the doctor’s office.
Lead author Robert Kerrison, of University College London, Cancer Research UK health behavior unit, said that, “everybody forgets things now and then and appointments to see the doctor make no exception…. In fact,” he added, “forgetting is the most common reason why women do not attend their breast cancer screening appointments.” His research proves that something as simple as a text message can increase the number of women who attend their appointments and get this important and potentially life-saving exam.
Breast Cancer News
Pilot Grants Awarded to Research How Breast Cancer Develops
March 24, 2015
Last week, the Dr. Susan Love Research Foundation, which is dedicated to achieving a future without breast cancer by engaging the public and the scientific communities in innovative research on cause and prevention, awarded four pilot grants to research projects exploring the human breast and how it develops cancer using next generation technology. The grants, funded by the Susan G. Komen organization and Atossa Genetics, will provide researchers with the ability to explore new theories and directions in the development of breast cancer.
The grants were awarded at the 8th International Symposium on the Breast, a unique assembly that gathers world-class researchers, clinicians and advocates in an intimate think-tank environment. of some of the best minds in breast cancer research. Dr. Love, speaking at the symposium, said, ““This Symposium is a unique assembly of many of the best minds in breast cancer research. Our approach to multidisciplinary collaborations inspires the exploration of ideas that may be too novel or preliminary for traditional funding mechanisms.”
Given the task of answering the fundamental question “How does breast cancer develop?, four teams will utilize recent advances in technology to explore the cause of this disease. The first $16,000 grant went to a consortium of researchers who will explore whether immune profiling of lymphocytes in women with benign breast disease can predict who will go on to develop breast cancer. This research could lead to the identification of new predictive markers for breast cancer risk and opportunities for prevention.
The second grant, of $17,000, will study optical coherence tomography (OCT), typically used in cardiology to look at blood vessels from the inside using light instead of sound to create three-dimensional images. OCT may be able to identify early changes in the breast duct before ductal carcinoma in situ (DCIS) or cancer forms. This study will determine whether it is feasible to use OCT to distinguish different types of breast cells and tissues and whether OCT can show features of invasive cancers or DCIS that are detected on ultrasound or mammography. This work could identify reproducible ways to image early changes in the ducts and set the stage for prevention studies.
A third grant, also in the amount of $17,000, will be used to analyze the overexpression of a tight junction protein called Junctional Adhesion Molecule-A (JAM-A ) in ductal carcinoma in situ (DCIS), to determine if this expression correlates with clinical factors, and to investigate whether treatments delivered directly into the breast ducts could target JAMA-A and prevent or reduce DCIS in animal models of breast cancer. This research could lead to prevention of invasive breast cancer through a local means.
The fourth and final grant was the Atossa Award of $20,000, which will help in the study of the safety and effectiveness of intraductal flagellin in animal models, with the ultimate goal of conducting a clinical trial of intraductal flagellin in breast cancer patients. This may serve as a way to prevent invasive breast cancer from developing.
Breast Cancer News
Second Opinion on Biopsies?
March 18, 2015
Not all breast cancer biopsies reveal specific results, as some are more nebulous and open to interpretation. Which is why a new study, published in the journal JAMA, might make a woman think twice about seeking a second opinion.
The study found that there are differing opinions by doctors when it comes to diagnosing breast biopsy tissue. When diagnosing invasive breast cancer, broad consensus was found 96% of the time. With non-cancerous biopsies agreement was found 87% of the time, but 13% of those were misdiagnosed. The bigger issue was when it came to the less obvious cases, and pathologists only agreed with outside experts 75% of the time, and when it came to the more challenging cases, such as atypia, when the pathologists only agreed 48% of the time.
This type of study questions the over-diagnoses and over-treatment of cancer that result from certain types of biopsies. The conclusion found that “In this study of pathologists, in which diagnostic interpretation was based on a single breast biopsy slide, overall agreement between the individual pathologists’ interpretations and the expert consensus–derived reference diagnoses was 75.3%, with the highest level of concordance for invasive carcinoma and lower levels of concordance for DCIS and atypia. Further research is needed to understand the relationship of these findings with patient management.”
Approximately 1.6 million women have a biopsy each year in the United States, the only way to accurately determine if cancerous cells are present. Only about 20%—or 320,000—of those are determined to be cancerous.
Breast Cancer News
Modifying Behavior to Lower Breast Cancer Risk
While there is no formula for determining who will actually get breast cancer in their lifetime, there could be ways to lower your risk overall, according to Dr. Ann Partridge, associate professor at Harvard Medical School, and founder and director of the Program for Young Women with Breast Cancer.
In a recent interview on “Take Care,” Dr. Partridge explained that eliminating environmental toxins and avoiding estrogen are a good start, but there are also individual behaviors that can affect risk. For women who have been through menopause and are overweight, there is an elevated chance of breast cancer. This is also true of women who are overweight in general. While it’s not know why weight plays such an important factor, Dr. Partridge says many scientists believe that being overweight has to do with “energy balance,” and hormones could also play a part.
“Women who are overweight often have higher levels of estrogen,” Partridge says. “It probably also has to do with the hormone insulin. Women who are overweight tend to have higher levels of insulin and people who don’t exercise also tend to have higher levels.”
Women can work to bring their body mass index (BMI) more in line with standards through diet and regular exercise. These behaviors could lower your risk of breast cancer. As can the elimination of cigarettes and alcohol, both of which are risk factors.
You can read the complete article, and watch the video interview with Dr. Ann Partridge here.
DIY Health News
CES 2015: Digital Health Devices
Reports at the conclusion of this year’s Consumer Electronics Show in Las Vegas all point to consumer DIY health care apps and devices being a dominant topic and taking up significant floor space. Among the forecasts for 2015 are the burgeoning sales of health and fitness wearables (Jawbone, Fitbit, Garmin, etc.), slated to hit the 20 million mark.
Making their debut at the show were a number of activity trackers, sleep devices, an oral health tracker, connected weight scales, and a several adhesive temperature devices. I particularly like the idea of the AmpStrip by Fitlinxx, a small patch with embedded sensor that adheres to the torso and tracks heart rate, calories burned, respiration, body temperature, and posture. And parents will appreciate TempTraq by Blue Spark Technologies, which is a peel-and-stick Bluetooth thermometer patch. Place it on your child during illness and fever and track their temperature with your smartphone!
Technology, miniaturization, and app development are all converging to bring new consumer health care products to the market, all pending FDA approval, of course.
DIY Health News
DIY Health Care: #1 Trend in Health in 2015
The Health Research Institute of PricewaterhouseCoopers has issued a report, “Top Health Industry Issues of 2105,” naming the emerging market of DIY Healthcare as the #1 trend. Noting that the $2.8 trillion health care industry is undergoing a “profound transformation,” the report sheds light on how the consumer-driven market is taking shape by developing innovative products and services.
In what they call the “New Health Economy,” data shows that “high-tech personal medical kits could help diagnose illness and flag early signs of trouble…” Much of this is spurred by Millennials, the generation that has been raised on technology, and an increasingly health-conscious society. It’s also one way of potentially reducing the amount of money spent on health care, necessitated by many who are uninsured or underinsured. DIY Health Monitoring can reduce doctor visits and unnecessary testing, as well as relieve anxiety by providing immediate results in a home environment.
In the first 10 months of 2014, the FDA cleared 24 digital health devices and more devices are awaiting clearance in 2015. 2015 will also see the FDA reviewing a record number of mobile health apps “as digital companies respond to the demand for more sophisticated mHealth products.” This is good news for consumers who will have the ability to proactively manage portions of their healthcare.