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Moleac Announces US FDA Approval of IND Application for Phase 1 Study of MLC1501 Programme in Post-Stroke Recovery

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SINGAPORE, March 5, 2018 /PRNewswire/ — Moleac, a biopharmaceutical company focused on research and development of new medicines for central nervous system (CNS) diseases and injuries, today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for a Phase 1 study of MLC1501, as first step of a clinical programme in post-stroke recovery treatment. Approval of this IND enables Moleac to initiate a safety study of MLC1501 in normal subjects as part of the overall clinical development plan for demonstrating that MLC1501 improves functional independence and recovery of motor, speech, cognition and other neurological dysfunctions in post-acute ischemic stroke (AIS) survivors having not recovered after acute treatments (thrombolysis, thrombectomy) or having not received them. Beyond the acute phase, there are no available treatments, other than rehabilitation measures, to relieve the disabilities suffered by stroke survivors. Proving clinical safety and efficacy of MLC1501 on long-term functional and neurological recovery in patients suffering from AIS will fill a therapeutic gap and help reduce the overall burden of stroke.

This is a clear milestone for Moleac to commence development of MLC1501 an agent that has proven successful in Asia for use in the USA as a new treatment for post-stroke recovery, an area where we need more agents to reduce the devastating burden of stroke for patients and their families,” said professor Lou Caplan of Beth Israel Deaconess Medical Center and Harvard University. “We already have learned much about the properties of the parent compound, NeuroAiD. This information will guide the clinical development of MLC 1501, and trials of its use in the USA.” Prof Caplan added.

David Picard, CEO of Moleac, added, “The US FDA’s clearance of this IND is validating our collaborative and determined approach to move into registration trials for post-stroke recovery. We are confident and eager that this Phase I study will confirm the safety of MLC1501 for starting as early as possible Phase II with international stroke centers and patients. We are grateful to all our colleagues, our partners in academia and our corporate partners without whom this step forward would not have been possible.”

About Stroke

Stroke is considered among the world’s most debilitating diseases with high mortality rate and afflicts over 17 million people worldwide each year, of which more than 80% of cases are ischemic stroke. Stroke not only endangers the lives of victims but also burdens the families of the stroke survivors with significant caretaking and financial expenses.  Despite the use of revascularization treatments in AIS, a huge number of stroke survivors will suffer from disabilities causing a substantial impact on their day-to-day life and functioning, and a heavy financial burden on society.

About MLC 1501

MLC150is a further developed formulation consisting of four of the original nine herbs that are present in two parent formulations, MLC601 and MLC901 (NeuroAiD™). Pharmacological studies have demonstrated equivalent neuroprotective and neurorestorative properties of MLC1501 in nonclinical animal and cellular models of focal ischemia. Clinical trials of MLC601/MLC901 and systematic reviews of those trials showed benefit in improving functional and neurological recovery, in patients having functional impairment after an acute ischemic stroke.

About Moleac

Moleac is a biopharmaceutical company dedicated in finding, developing and commercializing worldwide new medicines for the unmet medical needs of patients suffering of central nervous system (CNS) diseases and injuries, such as stroke, dementia and traumatic brain injuries. To address therapeutic gaps, Moleac has pioneered a new drug development approach, looking at sources of innovation from Natural Medicines, hence shortening considerably drug development cycle time and investment to bring medicine to sufferers’ unaddressed needs. Moleac’s neurorestorative natural formulation NeuroAiD™ reaches patients in more than 30 countries where it is regulated.

Contact

Clément Dif, Business Development & Marketing Department
Emailclement.dif@moleac.com
Phone: +65-62113710
Web: www.moleac.com

NeuroAiD at ASEAN Neurological Association

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Moleac will attend the 12th Biennial Convention of ASEAN Neurological Association (ASNA) & 39th Annual Convention of Philippine Neurological Association (PNA), in Manila, Philippines from 21 to 24 November.

Prof. N Venketasubramanian (Ramani) from Singapore, one of the principal investigators of NeuroAiD’s landmark study, CHIMES-E, will present the following posters:

  • Synergistic Effect of Combining MLC601 and Rehabilitation on Post-Stroke Recovery – The CHIMES Study.
  • Targeting Stroke Patients with a Higher Potential of Long-term Benefit from Treatment: Insights from the CHIMES-E Study.
  • Comparison of Long-term Spontaneous Functional Recovery and Response to Treatment with MLC601 between Cortical and Non-cortical strokes – The CHIMES-E Study.

In addition, Moleac and E*Chimes (distributor of NeuroAiD in the Philippines) will host a Twilight symposium with renowned speaker Prof. Simeon Marasigan from the Philippines to introduce the NEURITES study on 22nd November, 17:00 – 19:00:

  • NEURoaid II (MLC901) Assessment in Cognitivitely Impaired Not Demented Subjects: A Pilot Double Blind, Placebo Controlled Randomized Trial in Efficacy and Safety (NEURITES) Study (Preliminary Report).

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

NeuroAiD at Asia Pacific Stroke Conference

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Renowned clinicians and researchers will present abstracts from the latest studies conducted on NeuroAiD, including the principal investigators of NeuroAiD’s landmark study, CHIMES-E, demonstrating the long-term benefits of a 3-month course in achieving functional independence:

  • Prof. Christopher Chen from Singapore:

Abstract: Comparison of Long-term Spontaneous Functional Recovery and Response to Treatment with MLC601 between Cortical and Non-cortical strokes – The CHIMES-E Study.

  • Prof. N Venketasubramanian (Ramani) from Singapore

Abstract: Targeting Stroke Patients with a Higher Potential of Long-term Benefit from Treatment: Insights from the CHIMES-E Study.

  • Prof. Nijasri Suwanwela from Singapore

Abstract: Synergistic Effect of Combining MLC601 and Rehabilitation on Post-Stroke Recovery – The CHIMES Study.

Refer to the APSC program for more details – 26th to 28th October, Nanjing, China.

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

NeuroAiD at World Congress of Neurology

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Moleac’s flagship product, NeuroAiD, will be presented at the 23rd Word Congress of Neurology during oral abstract presentations by A/Prof. Alice Theadom from New-Zealand.

    • A Randomized, Placebo-controlled Pilot Trial to Investigate the Safety and Efficacy of MLC901 (NeuroAiDIITM) in Adults Following Mild or Moderate Traumatic Brain Injury – 19th September, 11:40 – 11:50.

In addition, Moleac will be hosting a symposium on the 17th September with renowned researchers in the field of neurology, to cover the following topics:

    • Prof. Jose Navarro from the Philippines, one of the principal investigators of NeuroAiD’s landmark studies, CHIMES and CHIMES-E, will present NeuroAiD’s long-term benefits in post-stroke recovery and the latest analyses conducted on prognostic factors or poorer outcomes.
    • Prof. Marasigan from the Philippines, will introduce NEURITES, ongoing clinical trial on NeuroAiD in vascular cognitive impairments.

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

NeuroAiD presentations at European Stroke Conference

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NeuroAiD, Moleac’s main product, will be presented at the 26th European Stroke Conference on 24th May during abstract presentations on the 24th and 26th May by A/Prof. Narayanaswamy Venketasubrmanian:

  • Comparison of Long-term Spontaneous Functional Recovery and Response to Treatment with MLC601 between Cortical and Non-cortical strokes – The CHIMES-E study (24th May)
  • Targeting Stroke Patients with a Higher Potential of Long-term Benefit from Treatment: Insights from the CHIMES-E Study (26th May)
  • Synergistic Effect of Combining MLC601 and Rehabilitation on Post-stroke Recovery – The CHIMES Study (26th May)

In addition, Moleac will be hosting an evening symposium on the 25th May with recognised leaders in the field of stroke and pre-clinical research, to cover the following topics:

  • Prof. Tatjana Rundek from the Unites States will present her work on long-term prognosis and outcome of patients after stroke.
  • Prof. Michel Lazdunski from France, who has conducted several important preclinical studies on NeuroAiD with his team, will present neurorestorative strategies from natural substances.
  • Prof. N Venketasubramanian (Ramani) from Singapore, one of the principal investigators of NeuroAiD’s landmark studies, will present CHIMES and CHIMES-E key outcomes NeuroAiD clinical benefit on post-stroke recovery and insights regarding patients’ selection for clinical research.

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

NeuroAiD presentations at European Stroke Organisation Conference

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NeuroAiD, Moleac’s main product, will be presented at the 3rd European Stroke Organisation Conference on 16th May during the following poster presentations:

  • Synergistic Effect of Combining MLC601 and Rehabilitation on Post-stroke Recovery – The CHIMES Study
  • Targeting Stroke Patients with a Higher Potential of Long-term Benefit from Treatment: Insights from the CHIMES-E Study

NeuroAid data will also be presented during an abstract presentation on the 18th May by Prof. Christopher Chen, National University of Singapore:

  • Comparison of Long-term Spontaneous Functional Recovery and Response to Treatment with MLC601 between Cortical and Non-cortical strokes – The CHIMES-E study

In addition, Moleac will be hosting an evening symposium on the 16th May with world-class leaders in stroke research, to cover the following topics:

  • Prof. Pamela Duncan from the United States will present her extensive research on capturing outcomes after stroke.
  • Prof. Christopher Chen from Singapore, one of the principal investigators of NeuroAiD’s landmark studies CHIMES and CHIMES-E studies, will present the long term benefits of NeuroAiD on post-stroke recovery.
  • Dr. Boutarene and Dr. Bouabdallah from Algeria will present the observational study they conducted on NeuroAiD with NeST Registry.

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

Launch of NeuroAiD in Nigeria

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Helping patients reconnect with their lives remain our focus. This February, NeuroAiD will be launched in Nigeria in association with our local distributor, Bolar Pharmaceuticals. Nigeria is one of the most populous nations in Africa, and has recently faced an increasing prevalence of stroke (>250,000 in 2015*) and other cardiovascular diseases. NeuroAiD is bringing a unique evidence-based therapeutic opportunity for the victims to recover faster and better.

*Global Burden Disease 2015 data

Moleac awarded prize from Creative France – recognising the success of French entrepreneurs in Singapore

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“Entrepreneur” is a French invention for risk takers committed to innovate, and Moleac is a complete illustration of successful entrepreneurial biopharmaceutical company in Singapore.

A quote from his Excellency, Ambassador Benjamin Dubertret, French Ambassador in Singapore

“The “Creative Next” contest aims at showcasing French ingenuity and identifying inspirational French entrepreneurs or SMEs that have demonstrated creativity and innovation in their business. Thanks to its innovative therapeutic solutions to neurological diseases, finalist company Moleac perfectly embodies the essence of French “creativité”: an exceptional ability to innovate paired with scientific excellence and talent.”

In 2016, Moleac celebrated the 10 years’ anniversary of its flagship product, NeuroAiD.

NeuroAiD was initially launched in Singapore in 2006 and rapidly expended to over 35 countries worldwide. This innovative product fulfills a major therapeutic gap for stroke victims in their journey to recover their functional independence. Today, NeuroAiD is in the running to become Singapore’s first home-grown drug.

The idea was born in France and initially funded from Europe. We saw the opportunity to bridge the gap between Traditional Chinese Medicine (TCM) and Western medicine, two paths which usually don’t cross at all. The decision to locate the company in Singapore was based on the understanding of both Eastern and Western medicine here in Singapore, which is essential for NeuroAiD’s development. We also wanted to ensure our research and data could stand the scrutiny of clinicians internationally. In the past 10 years, NeuroAiD has undergone clinical trials in Singapore and internationally, demonstrating its efficacy in boosting recovery of neurological functions after a stroke. NeuroAiD has reached 20,000 patients last year and we are currently working towards obtaining full-fledged drug approval in the United States and Europe.

We are honored to receive this award from Creative France which represents wider recognition of our commitment to innovate and bring therapeutic solutions to thousands of stroke victims worldwide.

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

Prognostic Factors and Pattern of Long-Term Recovery with MLC601 (NeuroAiD™) in the Chinese Medicine NeuroAiD Efficacy on Stroke Recovery – Extension Study

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Cerebrovasc Dis 2017; 43:36-42

Published by S. Karger AG, Basel

This analysis from the CHIMES-E study shows that subjects with prognostic factors of poorer outcome get a higher benefit on post-stroke functional recovery with a 3-month course of NeuroAiD compared to placebo, with statistically significant differences seen as early as 3 months and persisting over the long term. At 12 months NeuroAiD almost doubles the chances of achieving functional independence. These results indicate that selection of subjects with poorer prognosis, particularly those with more severe NIHSS score and longer OTT* delay, as well as a longer follow-up period and treatment duration can maximize the recovery potential of subjects included in post-acute stroke clinical trials.

Authors: Narayanaswamy Venketasubramanian, Chun Fan Lee, Sherry H. Young, San San Tay, Thirugnanam Umapathi, Annabelle Y. Lao, Herminigildo H. Gan, Alejandro C. Baroque II, Jose C. Navarro, Hui Meng Chang, Joel M. Advincula, Sombat Muengtaweepongsa, Bernard P.L. Chan, Carlos L. Chua, Nirmala Wijekoon, H. Asita de Silva, John Harold B. Hiyadan, Nijasri C. Suwanwela, K.S. Lawrence Wong, Niphon Poungvarin, Gaik Bee Eow, Christopher L.H. Chen for the CHIMES-E Study Investigators

Keywords: Acute stroke, Stroke recovery, MLC601, NeuroAiD, Prognosis, Clinical trial, Long-term outcome

Abstract:

Background: The Chinese Medicine NeuroAiD Efficacy on Stroke recovery – Extension (CHIMES-E) study is among the few acute stroke trials with long-term outcome data. We aimed to evaluate the recovery pattern and the influence of prognostic factors on treatment effect of MLC601 over 2 years.

Methods: The CHIMES-E study evaluated the 2 years outcome of subjects aged ≥ 18 years with acute ischemic stroke, National Institutes of Health Stroke Scale (NIHSS) score 6–14, pre-stroke modified Rankin Scale (mRS) score ≤ 1 included in a multicenter, randomized, double-blind, placebo-controlled trial of MLC601 for 3 months. Standard stroke care and rehabilitation were allowed during follow-up with mRS score being assessed in-person at month (M) 3 and by telephone at M1, M6, M12, M18 and M24.

Results: Data from 880 subjects were analyzed. There was no difference in baseline characteristics between treatment groups. The proportion of subjects with mRS score 0–1 increased over time in favor of MLC601 most notably from M3 to M6, thereafter remaining stable up to M24, while the proportion deteriorating to mRS score ≥ 2 remained low at all time points. Older age (p < 0.01), female sex (p = 0.06), higher baseline NIHSS score (p < 0.01) and longer onset to treatment time (OTT; p< 0.01) were found to be predictors of poorer outcome at M3. Greater treatment effect, with more subjects improving on MLC601 than placebo, was seen among subjects with 2 or more prognostic factors (OR 1.65 at M3, 1.78 at M6, 1.90 at M12, 1.65 at M18, 1.39 at M24), especially in subjects with more severe stroke or longer OTT.

Conclusions: The sustained benefits of MLC601 over 2 years were due to more subjects improving to functional independence at M6 and beyond compared to placebo. Selection of subjects with poorer prognosis, particularly those with more severe NIHSS score and longer OTT delay, as well as a long follow-up period, may improve the power of future trials investigating the treatment effect of neuroprotective or neurorestorative therapies.

 

Download the full paper

Moleac’s Flagship Product NeuroAiD Named Asia Pacific Neurological Disorders New Product Innovation of the Year At the Frost & Sullivan Best Practices Awards

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NeuroAiDTM has been named New Product Innovation of the Year by Frost & Sullivan. This award recognizes healthcare products that are bringing innovative solutions for neurological disorders by pushing the boundaries of the usual practices. This award also acknowledges Moleac for its effort and continuous investment in NeuroAiDTM‘s Research and Development. Mr. David Picard, CEO of Moleac, received the 2016 Frost & Sullivan Asia Pacific New Product Innovation Award at the awards ceremony held this evening at Conrad Singapore. The ceremony was attended by leaders from the healthcare sector.

Frost & Sullivan followed a rigorous measurement-based methodology to select NeuroAiDTM as the recipient. Its independent panel of judges included senior members across various offices at Frost & Sullivan. The judging panel looked at market performance indicators, including revenue growth, market share, availabilities, geographical expansion and marketing strategies. The full  Frost & Sullivan Award Research Report for Moleac is available here.

Dr. M. Shaillender, Industry Analyst, Healthcare Practice – Asia Pacific at Frost & Sullivan, said, “Stroke rehabilitation is an underserved segment in the pharmaceutical industry. Moleac aims to address the existing gaps in stroke therapy with an unconventional approach similar to reverse innovation.’ NeuroAiDTM is a product originating from Traditional Chinese Medicine that has demonstrated excellent attributes in post-stroke recovery, however, without any scientific and clinical evidence. Moleac’s team was instrumental in identifying and decoding the underlying neuromodulatory properties to translate it into a therapeutic drug supported by clinical evidence for neurological disorders.”

He further adds, “As one of the first therapies of its kind, NeuroAiDTM is today accepted as an innovative treatment for post-stroke recovery. It is approved and marketed in over 35 countries as a supplement for stroke rehabilitation. Executing well in its vision, Moleac is on a trajectory to expand the horizons of NeuroAiDTM into a mainstream therapeutic drug for neurological disorders.”

David Picard, CEO of Moleac, said, “I am delighted to receive this award from Frost & Sullivan while we are celebrating the 10 years’ anniversary of NeuroAiDTM. Having launched NeuroAiDTM in 2006, we have been focusing our efforts on making NeuroAiDTM available to stroke sufferers around the world. NeuroAiDTM is the first medicine to support stroke recovery, and this is a huge unserved need for millions of suffers. In 2016, over 20,000 patients benefited from NeuroAiDTM worldwide and we aim at making NeuroAiDTM available to more patients in the coming years.”

He continued to add, “I would like to thank all those who have contributed to NeuroAiDTM‘s development over the past 10 years. This includes our academic partners, who have shown interest in our approach enabling its clinical development, our investors who have trusted us, and of course my colleagues who have made this venture a success. Without their support, NeuroAiDTM would not be where it is today. We keep investing in Research with several on-going clinical studies to provide first-class evidences of NeuroAiDTM‘s benefits in other unserved neurological disorders.”

NeuroAiDTM is a natural medicine originating from Traditional Chinese Medicine. In addition to its excellent safety profile, clinical trials have shown that patients taking NeuroAiDTM for 3 months have higher chances to reach functional recovery, with prolonged benefits over the long-term as published in Cerebrovascular Diseases (April 2015). About 3,000 subjects have been included in clinical trials and Moleac is currently supporting additional international clinical trials to demonstrate the potential of NeuroAiDTM in other neurological disorders.

About Moleac: Moleac is a Singapore-based biopharmaceutical company that dedicates itself to finding and developing new medicines for the unmet needs of patients worldwide.

About NeuroAiDTM: NeuroAiDTM is a post-stroke recovery treatment to help stroke survivors achieve a faster and better recovery. Moleac also markets NeuroAiD II, a simplified formula. Both products are shown to be equivalent in pharmacology. It currently reaches out to patients in over 35 countries.