Optiscan Improving Cancer Outcomes with Digital Pathology& Precision Surgery
A brief dissertation.
Introduction
It is timely for a review of Optiscan and provide some orientation and perspective on the Company at present. This will be particularly useful for potential new shareholders. It is correct that the current share price is ridiculously low at sub 10 cents. This is an aberration and represents a unique buying opportunity. It is also an ideal time to buy, to take advantage of the 50% capital gains tax discount on sale if you hold the share for a minimum of 12 months - applicable to Australian tax residents. The share price will achieve $1 and a lot more, subject to the possibility of a company buy-out before then. The top twenty shareholders now own approximately 70% of the shares and they are not trading those shares. Recently some significant shareholders have increased their holdings. Most current trading is by day traders. Many Optiscan staff also own shares.
In summary, the share price will go through at least 8 price phases:
(1) The announcement of the submission of the FDA approval application for InVivage
(2) Increased income stream from Carl Zeiss Meditech and other sales, rentals and revenue
(3) The announcement of FDA approval
(4) The subsequent sales of InVivage
(5) The production of a prototype device for use in breast cancer surgery
(6) An upgraded GI device - Second Generation Flexible Scope for colonoscopy, gastroscopy, and endoscopy
(7) CE and TGA approvals for InVivage
(8) Further expansion of the product range including surgical and pathology
As you are aware the submission of the FDA approval application is imminent. And FDA approval will most likely occur in 2024. Recently the company received a $672,320 research and development tax rebate from the ATO for the 2022/23 financial year. In addition, to a recent $3 million Cooperative Research Centres Projects grant infusion [to be paid over 4 years] to allow Optiscan to continue work on its Edge-AI-enabled gastrointestinal endomicroscope which is a $9.2 million project collaboration with Australian industry and science partners the CSIRO, Hydrix and Design & Industry.
There is no doubt that the technology is sound and it works, evidenced by a successful capital raise in July 2023 of $16.7 million.
What is Cancer?
Cancer is a disease of the body’s cells. Cancer occurs when the cells in the body grow uncontrollably. Cancer is caused by mutations [changes] to the cell’s DNA.
Optiscan Products
ViewnVivo provides 3D single-cell live imaging for pre-clinical and research purposes. ViewnVivo applications include: cancer research; cell tracking, monitoring of infection and treatment; pathology; microvascular studies; tissue regeneration including stem cell research; photodynamic therapy; pharmacology including monitoring effects of drug delivery and tissue response; tissue injury and disease modelling; molecular imaging. And is compatible with multiple dyes and contrast agents.
InVivage is an intra-oral [within the mouth] digital microscope that provides images [including 3D] at a sub-cellular level [within a cell] for use in humans. Cells are the basic building blocks of life that can live on their own and make up all the living organisms and tissues of the body. Tissue is a group of cells that have a similar structure and function together. On average, depending on a few variables, a human has 28 to 36 trillion cells. An InVivage image can distinguish at a cellular level three types of tissue: (1) normal; (2) precancerous; (3) cancerous. The device in real time can be used for prevention, detection, and treatment of cancer. Significantly, the images become a part of a patient’s medical photo history that can be instantly transported around the world and subjected to AI analysis. The technology is critical in live cancer surgery for the identification of the margin between cancerous and non-cancerous cells. A de-novo application for FDA approval is imminent [within a month ortwo]. FDA approval will occur and most probably be this year. InVivage will have a software user interface, AI, and telepathology compatibility. In addition to the current development of sterile disposable sheaths and drapes. Subsequent by-products will include a surgical device for intraoperative live in vivo imaging for immediate surgical decision making with an initial target market in open breast surgery.
Future Offshoots from InVivage
Soon after FDA approval, the InVivage family will grow to include standalone devices for:
(1) Surgical (includes breast cancer) to enable the surgeon to distinguish the margin zone between cancer and non-cancerous tissue. Work on this is currently progressing, including InVivage’s rigid scope being adapted for laparoscopic surgical methods.
(2) Cervical - C1-C7 vertebrae which are separated from one another by intervertebral discs
(3) Pathology on fresh or fixed tissue – e.g. for breast cancer, neurosurgery. And use of dyes for added differentiation. Development started in December 2023.
(4) Gastrointestinal endomicroscopy - Optiscan has the precedent FDA approved Pentax device ISC-1000 – leading the pathway for a Second-Generation Flexible Scope for colonoscopy, gastroscopy, and endoscopy. The Current Procedural Terminology (CPT) codes offer medical practitioners a uniform language for coding medical services and procedures to streamline reporting, increase accuracy and efficiency in North America. The device currently has existing CPT codes 43206 Esophagoscopy flexible, transoral; with optical endomicroscopy 43252 Esophagogastroduodenoscopy, flexible, transoral; with optical endomicroscope 88375 Optical endomicroscopic image(s), interpretation and report, real time or referred, each endoscopic session 0397T Endoscopic retrograde cholangiopancreatography (ercp), with optical endomicroscopy (list separately in addition to code for primary procedure).
(5) Veterinary – lower regulatory burden – from small animal veterinary clinic to specialised large animal facilities
Advantages of Optiscan’s technology
The advantages of Optiscan’s technology include:
(1) No physical biopsy required
(2) Is not destructive to the tissue
(3) Immediate
(4) Live tissue analysis
(5) Unlimited number of samples
(6) Digital images anytime anywhere - remote-access in vivo images
(7) Photo history
(8) AI technology
(9) Histopathology
Carl Zeiss Meditec Convivo collaboration with Optiscan
Optiscan Confocal Imaging Technology is presently the primary imaging component of the ZEISS CONVIVO, providing live microscopic imaging technology in the field of Neurosurgery. The confocal laser scanning microscopy is used in combination with the contrast agent fluorescein sodium to visualize cellular and architectural characteristics of tissue with high resolution. Optiscan’s half-year report for 31 December 2023 indicated that Zeiss Meditec orders to date were $720,000. Optiscan’s Quality Management System successfully passed an ISO 13485:2016 Annual Surveillance Audit, in addition to an external audit as part of its agreement with Carl Zeiss Meditec.
The Current Status of Human Cancer Prevention andTreatment
(1) Increasing cancer rates worldwide
(2) current cancer surgery is inaccurate
(3) reoccurring cancer
(4) biopsy samples do not cover the entire tissue area
(5) biopsy results take time
(6) human error in the interpretation of samples
(7) inefficient cancer treatment that is costly
(8) limited access to interpretations of biopsy samples
Patents
A patent protects any device, substance, method or process that's new, inventive and useful. A patent lasts up to 20 years (standard patent) and 25 years for a pharmaceutical patent. An invention to be patentable must be:
New — it must be novel
Useful — it can be made or used in an industry
Inventive — it's different enough to what already exists
A suitable subject matter, known as 'manner of manufacture'.
Below is a list of Optiscan’s patents, in order of newest to oldest:
Sterile sheath for confocal endomicroscopy scanner probe - patent number: 11559189
Optical scanner and scanned lens optical probe patent number: 10194788
Imaging method and apparatus patent number: 9510730
Scanner for an endoscope patent number: 9456734
Optical scanner and scanned lens optical probe publication number: 20160143517
Imaging method and apparatus publication number: 20150073270
Scanner for an endoscope publication number: 20130274597
Fibre bundle confocal endomicroscope patent number: 8057083
Compact confocal endoscope and endomicroscope method and apparatus patent number: 8047985
Optical element publication number: 20110178409
Imaging method and system publication number: 20110178395
Optical fiber scanning apparatus patent number: 7920312
Objective lens unit for endoscope patent number: 7695431
Tuning-fork-type scanning apparatus with a counterweight patent number: 7532375
Optical fiber scanning apparatus publication number: 20090015894
Optical connector patent number: 7401984
Fibre bundle confocal endomicroscope publication number: 20080137363
Condensing optical system, confocal optical system, and scanning confocal endoscope
Patent number: 7338439
Laser scanning confocal microscope with fibre bundle return patent number: 7330305
Fiber bundle for contact endomicroscopy publication number: 20080013900
Endoscope publication number: 20080004495
Method and apparatus for providing depth control or z-actuation patent number: 7294102
Tuning-fork-type scanning apparatus with a counterweight publication number: 20070242330
Endoscope patent number: 7267647
Light scanning device patent number: 7248390
Scanning method and apparatus patent number: 7123790
Electrically operated tuning fork patent number: 7010978
Scanning microscope with miniature head patent number: 6967772
Condensing optical system, confocal optical system, and scanning confocal endoscope publication number: 20050052753
Optical connector publication number: 20050025499
Method and apparatus for providing depth control or z-actuation publication number: 20040220453
Endoscope publication number: 20040158129
Z sharpening for fibre confocal microscopes patent number: 6567585
Optical fibre confocal imager with variable near-confocal control patent number: 5926592
Confocal microscope and endoscope patent number: 5659642
(I think this is all of them – let me know if I have missed any.)
Paula Fox Melanoma and Cancer Centre – Opens April 2024
Located at 545 St Kilda Road Melbourne Australia. The project issupported by government, the Fox Family, Minderoo Foundation [Andrew Forrest],and Monash University. The 5-storey cancer centre will have capacity to care for approximately 300 patients a day and will also have research laboratories. The centre will expand the capacity of existing Clinical Trial activity at Alfred Health and the laboratories will increase collaboration between research staff and clinicians from The Alfred and Monash University. I would expect that the centre would be most interested in acquiring Optiscan’s devices.
The Royal Melbourne Hospital
The Royal Melbourne Hospital, in Victoria, is one of Australia's leading public hospitals. It is a major teaching hospital for tertiary health care and engages in clinical research. The Royal Melbourne Hospital has 16 operating theatres and 3-day procedure rooms. Over 32,300 surgical operations a year are conducted. Clearly, we all understand the importance of in vivo [in the living body] digital biopsies for cancer detection and treatment. Significantly, there is another supernumerary use of InVivage in all surgical procedures not related to cancer. That is a proactive use of InVivage for cancer detection. The Royal Melbourne Hospital is another potential Optiscan customer.
Charlie Teo [Australian neurosurgeon] controversy is notthe real issue – Effective cancer removal is
Charlie Teo is not the real issue – Effective cancer removal is the issue – One which only digital technology can solve. Australian neurosurgeons are not performing digital biopsies during their operations. A surgeon cannot efficiently remove a malignant brain tumour without a live digital biopsy. Optiscan’s technology is the solution. A live digital biopsy allows the surgeon to identify the cancer margin zone.
No Night Shift Pathology services for Physical BiopsyAnalysis– Urgent Need for Digital Biopsies - Part of a healthy lung removed –Coroner Inquest informed
A South Australian coroner’s court in February 2023 was told that an Adelaide cardiothoracic surgeon removed part of a man’s lung based upon a biopsy sample that had been allegedly incorrectly analysed because the sample became cross-contaminated. A digital biopsy would have avoided this error. In fact, an Adelaide Pathology laboratory has closed its night shifts to prevent the occurrence of tired pathologists from misdiagnosing biopsy samples. In addition, the Inquest into the death of Dennis Jackson in Adelaide heard evidence that a pathologist was prone to making mistakes late at night. There are three issues: (1) Contamination of biopsy samples; (2) Pathologists misdiagnosing biopsy samples because they are tired; and (3) Negligent pathologists and poor laboratory work practises, including the cross contamination of samples. Details of the case follow: Date:10/02/2023 Court: Coroners Court 302 King William Street, Adelaide JudicialOfficer: Mr. I. L. White, Deputy State Coroner Case Title: Dennis CharlesJackson Hearing Type: Inquest
Optiscan is 100000% more significant than Cochlear
Cochlear is an Australian company which was formed in 1981. It designs and manufactures hearing implants and holds approximately 75 percent of the worldwide implant market. In 2011, Forbes named Cochlear as one of the world’s most innovated companies. Today Cochlear has a market capitalisation of $22.10 billion with a share price of $337.52.
Optiscan was formed around 1997. In October 1999 to March 2000 the share price peaked at $3.20 with a day closing high of $2.90. The share price is now 7.6 cents. Optiscan’s technological advances in the past 20 years are remarkable. Undeniably, Optiscan is now the global leader in the development of endomicroscopic imaging technologies. The technology enables real-time, in vivo imaging at the cellular level in human and animal tissue. With great respect to Cochlear, its company’s technology relates to the human ear (hearing) which is insignificant when compared to the impact of cancer on the human population. In no way degrading the significance of hearing disabilities. However, human cancers effect every person in the world. We all have friends or relatives who have cancer, if we do not have cancer ourself. In fact, if a human survives long enough, he or she will be affected by cancer. Optiscan’s technology’s impact on mankind is thousands of multiples more significant than Cochlear.
List of cancers relevant to Optiscan’s technology
Relevant to in vivo (in the living body) and ex-vivo (outside the living body).
First the most common cancers are:
Bladder Cancer
Breast Cancer
Colon and Rectal Cancer
Endometrial Cancer
Kidney Cancer
Leukaemia
Liver Cancer
Lung Cancer
Melanoma
Non-Hodgkin Lymphoma
Pancreatic Cancer
Prostate Cancer
Thyroid Cancer
Other Cancers
Acute Lymphoblastic Leukaemia (ALL)
Acute Myeloid Leukaemia (AML)
Adrenocortical Carcinoma
AIDS-Related Cancers
Kaposi Sarcoma (Soft Tissue Sarcoma)
AIDS-Related Lymphoma (Lymphoma)
Primary CNS Lymphoma (Lymphoma)
Anal Cancer
Astrocytomas, Childhood (Brain Cancer)
Atypical Teratoid/Rhabdoid Tumour, Childhood, Central Nervous System (Brain Cancer)
Basal Cell Carcinoma of the Skin (Skin Cancer)
Bile Duct Cancer
Bladder Cancer
Bone Cancer (includes Ewing Sarcoma and Osteosarcoma and Malignant Fibrous Histiocytoma)
Brain Tumours
Breast Cancer
Bronchial Tumours (Lung Cancer)
Burkitt Lymphoma – (Non-Hodgkin Lymphoma)
Carcinoid Tumour (Gastrointestinal)
Carcinoma of Unknown Primary
Cardiac (Heart) Tumours, Childhood
Central Nervous System
Atypical Teratoid/Rhabdoid Tumour, Childhood (Brain Cancer)
Medulloblastoma and Other CNS Embryonal Tumours, Childhood (Brain Cancer)
Germ Cell Tumour, Childhood (Brain Cancer)
Primary CNS Lymphoma
Cervical Cancer
Cholangiocarcinoma – (Bile Duct Cancer)
Chordoma, Childhood (Bone Cancer)
Chronic Lymphocytic Leukaemia (CLL)
Chronic Myelogenous Leukaemia (CML)
Chronic Myeloproliferative Neoplasms
Colorectal Cancer
Craniopharyngioma, Childhood (Brain Cancer)
Cutaneous T-Cell Lymphoma - Lymphoma (Mycosis Fungoides and Sezary Syndrome)
Ductal Carcinoma in Situ (DCIS) – (Breast Cancer)
Embryonal Tumours, Medulloblastoma and Other Central Nervous System, Childhood (Brain Cancer)
Endometrial Cancer (Uterine Cancer)
Ependymoma, Childhood (Brain Cancer)
Oesophageal Cancer
Esthesioneuroblastoma (Head and Neck Cancer)
Ewing Sarcoma (Bone Cancer)
Extracranial Germ Cell Tumour, Childhood
Extragonadal Germ Cell Tumour
Eye Cancer
Intraocular Melanoma
Retinoblastoma
Fallopian Tube Cancer
Gallbladder Cancer
Gastric (Stomach) Cancer
Gastrointestinal Carcinoid Tumour
Gastrointestinal Stromal Tumours (GIST) (Soft Tissue Sarcoma)
Germ Cell Tumours
Childhood Central Nervous System Germ Cell Tumours (Brain Cancer)
Childhood Extracranial Germ Cell Tumours
Extragonadal Germ Cell Tumours
Ovarian Germ Cell Tumours
Testicular Cancer
Gestational Trophoblastic Disease
Hairy Cell Leukaemia
Head and Neck Cancer (we have seen a recent study of this!)
Heart Tumours, Childhood
Hepatocellular (Liver) Cancer
Histiocytosis, Langerhans Cell
Hodgkin Lymphoma
Hypopharyngeal Cancer (Head and Neck Cancer)
Intraocular Melanoma
Islet Cell Tumours, Pancreatic Neuroendocrine Tumours
Kaposi Sarcoma (Soft Tissue Sarcoma)
Kidney (Renal Cell) Cancer
Langerhans Cell Histiocytosis
Laryngeal Cancer (Head and Neck Cancer)
Leukaemia
Lip and Oral Cavity Cancer (Head and Neck Cancer)
Liver Cancer
Lung Cancer (Non-Small Cell, Small Cell, Pleuropulmonary Blastoma, and Tracheobronchial Tumour)
Lymphoma
Male Breast Cancer
Melanoma
Melanoma, Intraocular (Eye)
Merkel Cell Carcinoma (Skin Cancer)
Mesothelioma, Malignant
Metastatic Cancer
Metastatic Squamous Neck Cancer with Occult Primary (Head and Neck Cancer)
Midline Tract Carcinoma with NUT Gene Changes
Mouth Cancer (Head and Neck Cancer)
Multiple Endocrine Neoplasia Syndromes
Multiple Myeloma/Plasma Cell Neoplasms
Mycosis Fungoides (Lymphoma)
Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
Myelogenous Leukaemia, Chronic (CML)
Myeloid Leukaemia, Acute (AML)
Myeloproliferative Neoplasms, Chronic
Nasal Cavity and Paranasal Sinus Cancer (Head and Neck Cancer)
Nasopharyngeal Cancer (Head and Neck Cancer)
Neuroblastoma
Non-Hodgkin Lymphoma
Non-Small Cell Lung Cancer
Oral Cancer, Lip and Oral Cavity Cancer and Oropharyngeal Cancer (Head and Neck Cancer)
Osteosarcoma and Undifferentiated Pleomorphic Sarcoma of Bone Treatment
Ovarian Cancer
Pancreatic Cancer
Pancreatic Neuroendocrine Tumours (Islet Cell Tumours)
Papillomatosis (Childhood Laryngeal)
Paraganglioma
Paranasal Sinus and Nasal Cavity Cancer (Head and Neck Cancer)
Parathyroid Cancer
Penile Cancer
Pharyngeal Cancer (Head and Neck Cancer)
Pheochromocytoma
Pituitary Tumour
Plasma Cell Neoplasm/Multiple Myeloma
Pleuropulmonary Blastoma (Lung Cancer)
Pregnancy and Breast Cancer
Primary Central Nervous System (CNS) Lymphoma
Primary Peritoneal Cancer
Prostate Cancer
Rare Cancers of Childhood
Rectal Cancer
Recurrent Cancer
Renal Cell (Kidney) Cancer
Retinoblastoma
Rhabdomyosarcoma, Childhood (Soft Tissue Sarcoma)
Salivary Gland Cancer (Head and Neck Cancer)
Sarcoma
Childhood Rhabdomyosarcoma (Soft Tissue Sarcoma)
Childhood Vascular Tumours (Soft Tissue Sarcoma)
Ewing Sarcoma (Bone Cancer)
Kaposi Sarcoma (Soft Tissue Sarcoma)
Osteosarcoma (Bone Cancer)
Soft Tissue Sarcoma
Uterine Sarcoma
Sézary Syndrome (Lymphoma)
Skin Cancer
Small Cell Lung Cancer
Small Intestine Cancer
Soft Tissue Sarcoma
Squamous Cell Carcinoma of the Skin - Skin Cancer
Squamous Neck Cancer with Occult Primary, Metastatic (Head and Neck Cancer)
Stomach (Gastric) Cancer
T-Cell Lymphoma, Cutaneous - Lymphoma (Mycosis Fungoides and Sezary Syndrome)
Testicular Cancer
Throat Cancer (Head and Neck Cancer)
Nasopharyngeal Cancer
Oropharyngeal Cancer
Hypopharyngeal Cancer
Thymoma and Thymic Carcinoma
Thyroid Cancer
Tracheobronchial Tumours (Lung Cancer)
Transitional Cell Cancer of the Renal Pelvis and Ureter (Kidney (Renal Cell) Cancer)
Unknown Primary, Carcinoma of
Ureter and Renal Pelvis, Transitional Cell Cancer (Kidney (Renal Cell) Cancer
Urethral Cancer
Uterine Cancer, Endometrial
Uterine Sarcoma
Vaginal Cancer
Vascular Tumours (Soft Tissue Sarcoma)
Vulvar Cancer
Wilms Tumour and Other Childhood Kidney Tumours
Conclusion
Optiscan’s technology is a consequence of 25+ years of research and development.
Between $500 million to $1 Billion has been spent by Optiscan to achieve what we have today.
The company currently has an experienced and competent board, who are across the medical technology and the commercial issues which they are addressing head on
InVivage FDA approval will occur and coincides with the start of the significant evolution in artificial intelligence
Optiscan’s technology applies to all cancers
Carl Zeiss’ neurosurgery platform continues to expand and exists solely because of Optiscan’s technology. Carl Zeiss Meditech continues to collaborate with Optiscan
The market for Optiscan’s technology over the next five years is over $10+ Billion.
The value of the Optiscan’s intellectual property is enormous.
Clearly, Optiscan’s True Value Exceeds $1 Billion.
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