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Lovely break of $3.00!!! Should have a little sideways trading here before the next leg up. 
$HSDT
Commercialized at 2 clinics (with 3 more expected this year) with regulatory clearance in Canada.
FDA already acknowledged the device's use has no AE's, they merely didn't see a justification in the metrics from the trials. Which seems crazy given that patients in Canada literally asked to meet the company to thank them personally for this life-changing product.
27.62% % of Shares Held by All Insiders
16.27% % of Shares Held by Institutions
22.48% % of Float Held by Institutions
Recently:
Increased Positions: 23 711,164
Decreased Positions: 15 132,180
Held Positions: 7 3,305,995
Total Institutional Shares 4,149,339
New Positions: 7 435,342
Sold Out Positions: 5 10,185
60 - Number of Institutions Holding Shares
O/S: 25,834,180
Float Possibly 10,000,000 or less
The company holds 28 US medical patents, 2 pending patents, 31 foreign design and utility patents.
https://www.otcmarkets.com/filing/html?id=13298772&guid=hw83UqqVMikwC3h
They currently have $9,854,000 in Net Assets as of the latest 10K
"On January 31, 2019, we formed another wholly owned subsidiary, Helius NeuroRehab, Inc., or HNR, a Delaware corporation, which will operate a clinical research site as well as a rehabilitation clinic that will provide the PoNS Treatment to patients with balance and gait disorder following our receipt of marketing authorization from the FDA."
The following are PoNS Trials in TBI and PoNS Registrational Clinical Trials:
We completed our registrational clinical trial of the PoNS Treatment for persons with mmTBI in 2017. It was a double-blind randomized, controlled study of the safety and effectiveness of the PoNS Treatment using translingual noninvasive stimulation in persons with chronic balance deficit due to mmTBI.
The trial was launched in 2015 in conjunction with the U.S. Army Medical Research and Materiel Command and was conducted at seven sites in the United States and Canada. The trial evaluated 122 randomized participants between the ages of 18 and 65 years. Each participant received five weeks of treatment, two weeks in clinic and three weeks at home. The treatment consisted of standardized targeted physical therapy geared toward the functional capability of each individual participant. Enrolled participants worked with a certified PoNS trainer and were randomized to receive either a high-frequency pulse, or HFP, (25.7 million pulses per 20-minute treatment) or a low-frequency pulse, or LFP, (13,728 pulses per 20-minute treatment) PoNS device. While the HFP and the LFP devices were identical, the frequency of the pulses were different.
Trial Design
All participants provided a prior neuroradiologic report (obtained at least one year after the most recent mmTBI), if available, and completed demographic and quality of life surveys and a medical history during an initial screening visit. Participants who met the initial screening entrance criteria were scheduled for an MRI of the head, a neuropsychiatric evaluation, the NeuroCom Sensory Organization Test, or SOT, to evaluate balance, and a 20-minute walk on the treadmill to evaluate fitness. Key eligibility criteria to participate in the study included the following:
Male or female, 18 to 65 years of age.
At least 1-year post most recent mmTBI at the time of screening.
Had participated in a focused physical rehabilitation program for mmTBI and had been deemed by their treating clinician to have reached a plateau.
Had a balance disorder SOT composite score of at least 16 points below the normative value for the participant’s age.
Stable neurologic status, as determined from the participant’s medical records and the trial physician’s opinion based on no new or changing symptoms.
Participants meeting all the eligibility criteria, and who were not disqualified by exclusion criteria applicable to the trial, were enrolled and randomly assigned in blocks of four to receive an HFP or LFP device. Randomization occurred at each site, according to the randomization plan developed by the clinical research organization. An objective balance assessment was performed using the composite score from the SOT, which measures balance using computerized sensors that objectively measure participants’ ability to maintain balance under six different conditions. The SOT is a widely used measurement tool for balance disorder associated with TBI and was used as the primary efficacy endpoint for the trial. According to published clinical trial data, patients that received physical therapy alone to treat balance deficit related to mmTBI improved by an average of ten to 13 points on the SOT scale, a 0 to 100 scale, and clinical experience shows those patients tend to drift back to their baseline disability when physical therapy is discontinued. On average, participants entered the trial with an SOT composite score of approximately 40, which is a score that indicates substantially compromised functional balance. In the trial, an SOT responder was defined as a participant with an improvement of at least 15 points in his/her SOT composite score from baseline to the end of five weeks of PoNS Treatment, a level of change that to our knowledge, has never been achieved in clinical trials of patients with mmTBI-related balance disorder undergoing standard of care physical therapy.
Trial Results
The trial’s statistical analysis plan stated that, if the outcome of the primary effectiveness endpoint showed that PoNS Treatment in the HFP and LFP arms both produced responses of greater than 15 points on the SOT composite score that were not significantly different from one another, the secondary endpoint would be calculated by combining the two groups and comparing the response to baseline at week two and week five. This would imply that both devices had a clinical effect.
The primary effectiveness endpoint demonstrated a trend toward a higher responder rate in the HFP arm (with 75.4% of subjects experiencing a greater than 15 point improvement on the SOT composite score) than in the LFP arm (with 60.7% of subjects experiencing a greater than 15 point improvement on the SOT composite score), p<0.081. The primary effectiveness endpoint was not reached because of the significant therapeutic effect observed in the LFP arm. Because both arms produced responses of greater than 15 points on the SOT composite score that were not significantly different from one another, the secondary effectiveness endpoint was calculated per the statistical analysis plan, as described above. The secondary effectiveness endpoints demonstrated statistically and clinically significant increases in SOT composite scores:
The mean improvement at two weeks for the pooled arms was 18.3 points, P<0.0005.
The mean improvement at five weeks for the pooled arms was 24.6 points, P<0.0005.
Since the majority of patients who have a chronic balance disorder associated with mmTBI are subjected to a higher risk of falls and headaches, the primary safety endpoint was an improvement in the frequency of falls as determined by daily event recording on the participant data case report form during the in-clinic phase of the study (week two). The secondary safety endpoint was the frequency and severity of headaches, as measured by the Headache Disability Index at baseline and at the end of treatment, which was at week five.
We successfully met the primary and secondary safety endpoints as measured by a decrease in falls at week two a decrease in headaches at week five, respectively, in both treatment groups.
There were no serious device related adverse events.
PoNS Long-Term Treatment Trial: A 26-Week Study
This study was performed to understand the durability of response to the PoNS Treatment. This double-blind randomized controlled study in patients with mmTBI was completed in 2017 at the Tactile Communication Neurorehabilitation Laboratory at the University of Wisconsin-Madison and was sponsored by the U.S. Army. The study was conducted with 22 and 21 participants randomized to the HFP and LFP PoNS Treatment arms, respectively. Participants underwent 14 weeks of active treatment identical in format to the treatment regime in our registrational clinical trial described above, followed by a 12-week washout period when participants discontinued the PoNS Treatment and were told to resume normal daily lifestyles with no specified physical therapy regime. SOT composite scores were captured at specific time points throughout the study, including at 14 weeks and after the 12-week washout (26 weeks).
Highlights of the study results were as follows:
There was no statistical difference between the HFP and LFP PoNS Treatment arms mirroring the results of the registrational clinical trial.
On average, participants entered the study with an SOT composite score of approximately 40, which is a score that indicates substantially compromised functional balance.
At the end of 14 weeks of active treatment with the HFP PoNS arm, patients showed improvements on average of 29.7 points on the SOT composite score.
After the 12-week washout period, the participants, on average, maintained the same SOT composite score as after 14 weeks of PoNS treatment.
Conclusion:
The study demonstrated that the PoNS Treatment could, on average, allow patients with mmTBI who had chronic balance deficit and other injury-related functional disabilities, achieve an SOT composite score in the normal range in 14 weeks and maintain that benefit after a 12-week washout period. We believe that this data supports the durability of the response to the treatment and the potential restoration of the balance system. Furthermore, in a subset of nine participants, sequential magnetic resonance imaging, or MRI, scans were performed that showed increased grey matter volume in the cerebellum and elsewhere, commensurate with improved balance.
Overall Conclusion From the Two mmTBI Trials.
We believe the most significant observations from the two mmTBI trials are:
Our registrational and long-term treatment trials combined were the largest neuromodulation trials in mmTBI with neuromodulation ever performed.
Participants who had a profound, chronic balance disorder resistant to conventional physical therapy, and with a prognosis of a lifetime of this disability were, on average, in the normal range of balance following the 14 weeks of treatment.
In a subset of nine participants, MRI scans revealed structural changes in the brain resulting from the neuromodulation inducing neuroplastic effect.
The PoNS Treatment in one data set also resulted, on average, in patients maintaining the improvement for at least a 12-week period suggesting a permanent improvement in participants’ chronic balance issues.
There were no differences in clinical outcomes across the clinical trial sites performing both trials.
There were no differences at baseline in age, sex, time from injury, amount of previous physical therapy, level of disability or adherence to therapy in each of the treatment groups.
The difference in therapeutic effect noted between high and low frequency pulse groups suggests that there was an independent device effect.
Regulatory Submissions
In October 2018, we received our Canadian marketing authorization allowing us to commercialize the PoNS Treatment in Canada.
In December 2018, we submitted an application for a CE Mark, which, if approved, would allow us to market the PoNS device in the EU.
Planned Studies
Multiple Sclerosis
The FDA has determined that we must obtain an investigational device exemption, or IDE, prior to commencing any clinical trial of the PoNS Treatment in patients with MS in the United States. We intend to commence a registrational clinical trial of the PoNS Treatment in MS patients with balance and gait deficit once we receive FDA clearance to market the PoNS Treatment for mmTBI, contingent on the availability of funding and the timing of our submission and approval of an IDE by the FDA.
Stroke
Stroke is the third leading cause of death in the United States, with approximately 795,000 annual episodes, resulting in approximately 140,000 deaths per year. The term “stroke” or “brain attack” implies brain tissue has been destroyed – because one of the vessels that provide oxygen and nutrients to the brain has ruptured or become blocked by atheromatous plaque or a blood clot traveling from elsewhere in the body, often due to an irregularly beating heart. Whichever mechanism leads to a stroke, the end result is the same; death of brain tissue and variable disability depending on what parts of the brain have been affected. The disability may be the inability to feel or move a part of the body, to speak, think, or many other possible symptoms. Acute treatment includes drugs, interventional radiology or surgery to stop bleeding or remove blockages. Thereafter, therapy is focused on trying to help the patient recover use of disabled anatomy with physical therapy or learn to overcome disability with occupational therapy. A published study conducted by a researcher at the Royal Melbourne Hospital in Australia observed that patients with sub-acute stroke induced balance issues experienced a statistically significant improvement in the mini balance evaluation systems test, a clinical balance assessment tool, following PoNS Treatment compared to physiotherapy alone. We are determining next steps for our studies of the PoNS Treatment for stroke patients, which are subject to the availability of funding.
Partnerships and Agreements
U.S. Army Partnership
In February 2013, we entered into a collaborative relationship with the U.S. Army pursuant to a February 2013 cooperative research and development agreement, as amended, or the CRADA, to determine if the PoNS Treatment could be developed for commercial use in the treatment of soldiers and others with a variety of military-relevant neurological manifestations of TBI, including tinnitus, post-traumatic stress disorder, pain and any subsequent indications identified by the parties.
In July 2015, we entered into a sole source cost sharing agreement, or the U.S. Army Agreement, with the U.S. Army for the commercial development of the PoNS Treatment for chronic balance deficits related to mmTBI. Pursuant to the U.S. Army Agreement, the laboratories of the U.S. Army Medical Material Agency, and the U.S. Army Medical Research and Materiel Command, or USAMRMC, (collectively, the “Army Laboratories”) agreed to cooperate with us on clinical studies and regulatory responsibilities necessary to obtain FDA marketing authorization for this indication. Under the U.S. Army Agreement, we were the sole regulatory sponsor and oversaw and executed all required clinical studies. Further, the U.S. Army reimbursed us for the initially budgeted costs related to the registrational clinical trial of the safety and effectiveness of the PoNS Treatment for chronic balance deficits related to mmTBI, up to a maximum amount of $3.0 million.
In November 2018, the Army Laboratories notified us of their intention to terminate the CRADA, effective December 31, 2018. In December 2018, the U.S. Army notified us that it was amending the U.S. Army Agreement to provide that our obligations under the contract were satisfied upon our submission of an application for marketing authorization of the PoNS device to the FDA.
Our satisfaction of the U.S. Army Agreement and the termination of the CRADA concluded our formal contractual relationships with the U.S. Army. We are currently focusing on partnering with the relevant departments in the U.S. Department of Defense, or DOD, and U.S. Department of Veterans Affairs, or Veterans Affairs, to obtain reimbursement, upon FDA marketing authorization, for U.S. military personnel using our PoNS Treatment.
As of December 31, 2018, we received a total of approximately $3.0 million with respect to reimbursements for expenses owed to us for completion of development milestones. All reimbursement amounts received were credited directly to research and development expenses.
Canadian Strategic Alliance
In September 2018, we entered into an exclusive strategic alliance agreement with Health Tech Connex, Inc., or HTC, and Heuro Canada Inc., or Heuro, a newly formed wholly owned subsidiary of HTC, to establish three founding clinics to treat patients and create a replicable model for future clinic expansion. Under the terms of the agreement, Heuro is responsible for the development of the clinic systems to facilitate the commercialization of the PoNS Treatment in Canada. The parties will contract with the clinics and develop a model for the clinics to deliver clinical services, featuring the PoNS Treatment, to manage neurological conditions. The parties are developing a clinical assessment plan to support the expansion of the neuroplasticity clinic system beyond the initial three founding clinics throughout Canada. The clinical assessment plan is a plan comprised of (i) the minimum criteria necessary for the parties to proceed with a clinical expansion plan and (ii) a framework for a replicable clinical model, which is anticipated to include among other things, policies and procedures, training modules, product distribution, storage and inventory requirements. The clinical expansion plan is a business plan for the expansion of the neuroplasticity clinic system beyond the initial three founding clinics throughout Canada through a franchise model.
A joint steering committee, or JSC, comprised of three representatives from each of HTC and Helius and one representative of Heuro, will oversee the establishment of the founding clinics and the development of the expansion plan to commercialize the PoNS Treatment and other clinical services. During the fourth quarter of 2018, the JSC approved and engaged two of the founding clinics to deliver the PoNS Treatment. In February 2019, we entered into supply agreements with these two founding clinics and we fulfilled our first commercial orders for the sale of the PoNS device. The founding clinics began treating patients in March 2019.
The agreement also provides for HTC to pay Helius CAD$750,000 in three annual payments of CAD$250,000 beginning December 31, 2019, in consideration for the exclusivity right we granted to Heuro. The term of the agreement is the earlier of September 2023 or the formal adoption of a clinical expansion plan. Under the terms of the agreement, each of Helius and HTC has agreed to fund up 50% of the Heuro’s operating budget as agreed to by the JSC not to exceed CAD$1 million each. Helius and HTC have also agreed to share in any net profits and losses of Heuro on a 50/50 basis.
China Strategic Agreement
In October 2015, we entered into a strategic agreement with A&B (HK) Company Ltd., or A&B, an investment and development company based in Hong Kong for the development and commercialization of the PoNS Treatment in China, Hong Kong, Macau, Taiwan and Singapore, collectively referred to as the Territories. The agreement transferred ownership of certain Asian patents, patent applications, and product support material for the PoNS device from us to A&B and granted to A&B, among other things, an exclusive license to market, promote, distribute and sell the PoNS devices solely within the Territories.
Now for the drop that occurred recently:
FDA denied them "Do Novo" status, but they're already underway commercializing the PoNS in Canada with a minimum of revenue of $1.6-$2MM this year based solely on the 2 signed clinics
"U.S. Food and Drug Administration has declined its request for De Novo classification and clearance of its Portable Neuromodulation Stimulator device (PoNS). The agency said it did not have enough data to determine the relative contributions of the device and physical therapy in clinical studies, but said the company could generate additional data and resubmit its application."
https://www.otcmarkets.com/filing/html?id=13353004&guid=hw83UqqVMikwC3h#HSDT-EX991_6_HTM
In 2015 the company saw a similar drop from over $10 down to $2.45 and within 3 months had recovered to $5.75
The recent candles show every white soldier bullish candle is slightly bigger than the prior which is a well known notable bullish tech pattern that leads to increasingly larger white soldier candles everyday until a parabolic one occurs usually a 100% type day. At current levels I don't expect any such day to occur but I do anticipate the daily gains will steadily increase pushing this easily back over $5.00+ in the coming weeks.
Huge buys today $HSDT
Let’s see some nice gains today 
$HSDT
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