|Over a week ago|
Brainsway files $75M mixed securities shelf 09:4409/0409/04/20
|Over a month ago|
Brainsway receives 510(k) clearance from FDA for Deep TMS system » 07:1008/2408/24/20
BrainsWay announced that…
BrainsWay announced that it has received 510(k) clearance from the FDA for the company's deep transcranial magnetic stimulation, or Deep TMS, system for its use as an aid in short-term smoking cessation in adults. "This FDA clearance represents a significant milestone for BrainsWay and our Deep TMS platform technology," stated Christopher von Jako, president and CEO of BrainsWay. "Smoking is one of the leading causes of death in the U.S. and also leads to other serious conditions, such as lung cancer and heart disease. While other therapies are currently available, a substantial medical need continues to exist for treatments that can increase the continuous quit rate among smokers. Based on the compelling data from our large, randomized pivotal study of 262 subjects, we are confident that our Deep TMS technology can play an important role in treating cigarette smokers who seek to quit. We look forward to executing a controlled U.S. market release of our newly cleared and proprietary H4 Deep TMS coil for this indication early next year."
Brainsway reports Q2 EPS (3c), two est. (13c) » 07:2908/1208/12/20
Reports Q2 revenue $4.8M,…
Reports Q2 revenue $4.8M, two est. $4.77M. As of June 30, 2020, BrainsWay's Deep TMS installed base was 567 total systems, a 24% increase from the same period in 2019. "With most clinics having now reopened, we see patients steadily returning for Deep TMS treatments," stated Christopher von Jako, Ph.D., President and CEO of BrainsWay. "As mental health challenges have dramatically risen throughout the course of the ongoing COVID-19 pandemic, we remain focused on enhancing the awareness of and education about Deep TMS on multiple fronts. We also continue to execute our expense reduction plan in order to ensure our business is appropriately positioned to persevere in the current healthcare environment, while also strengthening our long-term growth prospects. We are proud of the resilience and commercial success our business has demonstrated under challenging circumstances, including sequential revenue growth of 16%, and expect that significant momentum in our business will emerge once the impact of COVID-19 subsides."
University TMS offers Brainsway's Deep TMS therapy » 09:0407/2107/21/20
University TMS is now…
University TMS is now offering BrainsWay's Deep Transcranial Magnetic Stimulation for major depressive disorder (MDD) and obsessive-compulsive disorder. BrainsWay's Deep TMS administers magnetic waves through a cushioned helmet to target deep structures of the brain that impact a patients' depression and OCD symptoms. The treatment is both noninvasive and medication-free, and patients can return to normal activities, such as driving, immediately following the session. Because Deep TMS penetrates deeper and broader in the brain than traditional TMS, it enables stimulation of the deep brain structures that are involved in mental health illnesses. BrainsWay has been treating depression with Deep TMS for more than 10 years and received FDA clearance to target OCD in 2018.
|Over a quarter ago|
Brainsway sees Q2 revenue $4.6M-$4.9M, consensus $4.3M » 07:3706/2406/24/20
While BrainsWay does not…
While BrainsWay does not intend to provide quarterly financial guidance as standard practice, given the extenuating circumstances caused by COVID-19, the Company believes that it is important that investors and analysts have an understanding of the current state of its business in this evolving healthcare environment. Therefore, for the second quarter of 2020, BrainsWay expects revenues to be in the range of $4.6M and $4.9M.
Brainsway reports Q1 EPS (15c), consensus (15c) » 07:3606/2406/24/20
Reports Q1 revenue $4.2M,…
Reports Q1 revenue $4.2M, consensus $4.55M. "We are pleased that many clinics are now reopening and progressing toward near-normal operations," stated Christopher von Jako, Ph.D., President and CEO of BrainsWay. "BrainsWay has remained fully operational in the U.S., as we recognize the importance of patients continuing to receive their Deep TMS treatment during the COVID-19 pandemic. In addition, we have established a number of new resources to address the significant negative impact on mental health that so many are facing during this challenging time. These resources include creating educational materials, launching a new website, and implementing a payment flexibility plan for new customers. BrainsWay has also executed a plan to decrease expenses, including reducing salaries and implementing other cost-saving measures. We believe that these actions, together with other enhancements to key foundational areas of our business, will ensure that we are well-positioned to support our customers in addressing the mental health challenges that surely lie ahead."
Brainsway appoints Judith Huber as CFO » 08:3905/0605/06/20
BrainsWay announced that…
BrainsWay announced that Hadar Levy has been promoted to Senior Vice President and General Manager of North America, and Judith Huber has been appointed the Company's Senior Vice President and CFO, effective May 11, 2020. Levy will oversee BrainsWay's North American business, including sales, operations, customer service, field engineering, and customer training. He is the Company's current CFO and COO. Huber served as CFO of NinePoint Medical, Inc., a privately-held, advanced image guidance company, where she led multiple financings.
Brainsway sees Q1 revenue $3.9M-$4.2M, consensus $5.35M » 07:3504/1304/13/20
"Our revenue estimate for the first quarter reflects the impact that the COVID-19 global health pandemic is having on our business," said Christopher von Jako, Ph.D., President and CEO. "This impact is due in part to certain new customers who have not previously offered deep transcranial magnetic stimulation treatment being unable to finalize orders or to accept delivery of ordered systems as a result of the temporary shutdown of certain physician offices and clinics. Importantly, as TMS treatments are often considered a medical necessity, many offices and clinics with existing TMS technology remain open and operational. Therefore, many patients in need are still receiving their Deep TMS treatment. With a large and growing installed base of Deep TMS systems in major depressive disorder and obsessive-compulsive disorder, BrainsWay is well-positioned to serve these individuals. Moreover, the Company is well positioned to fund our future growth due to our strong cash position and debt-free balance sheet. In order to limit the short-term impact of COVID-19 on our business, we have put in place a number of cost-cutting measures, such as reducing or temporarily eliminating our spend on travel, marketing-related events and various outside services, delaying salary raises, and freezing hires for certain positions. Longer-term, the challenges posed by COVID-19 globally to so many people are, unfortunately, likely to evolve into mental health issues for some. Once this health crisis subsides, we look forward to being able to provide these individuals with an effective and safe solution through our Deep TMS system." BrainsWay is applying for the Payroll Protection Program Loan under the recently passed CARES Act and, to the extent other loan and aid programs become available, will seek to participate in them as appropriate. The Company expects to report full first quarter financial results in June 2020.
The Remedy offers Brainsway's Deep TMS therapy » 09:1604/0704/07/20
The Remedy, a…
The Remedy, a person-centered mental health care facility offering advanced treatments, announced that it is now offering BrainsWay's Deep Transcranial Magnetic Stimulation for major depressive disorder and obsessive-compulsive disorder. For those reliant on Deep TMS sessions, The Remedy has implemented measures such as disinfecting all touched surfaces frequently, and after each patient visit, requiring providers to wear masks, and adhering to physical distancing as much as possible during sessions, and in the waiting area. Patients can learn more about The Remedy's response to the COVID-19 pandemic by visiting the company's dedicated page, which includes guidelines from the Centers for Disease Control and Prevention and tips to care for yourself physically, emotionally and spiritually. The company has also rebranded its website, allowing easier navigation and access to information. BrainsWay's Deep TMS administers magnetic waves through a cushioned helmet to target deep structures of the brain that impact a patients' depression and OCD symptoms. The treatment is both noninvasive and medication-free, and patients can return to normal activities, such as driving, immediately following the session. Because Deep TMS penetrates deeper and broader in the brain than traditional TMS, it enables stimulation of the deep brain structures that are involved in mental health illnesses. BrainsWay has been treating depression with Deep TMS for more than 10 years and received FDA clearance to target OCD in 2018.
Brainsway price target lowered to $9 from $13 at Raymond James » 07:2603/2403/24/20
Raymond James analyst…
Raymond James analyst Jayson Bedford lowered the firm's price target on Brainsway to $9 from $13 and keeps an Outperform rating on the shares following the company's Q4 results. In a research note to investors, Bedford says the results were slightly above expectations, adding that management sounded optimistic on business continuity despite the ongoing COVID-19 uncertainty/disruption.