Breastlight India

Using innovative, and affordable technology to improve breast

screening outcomes for the masses

Introduction

• The world’s first and only portable breast illumination device

• Based on simple, non invasive visual examination

• Sensitivity and specificity rates similar to mammography

• For screening at home or primary care• 25,000 units sold worldwide since 2008 in

more than 40 countries

Breastlight In Use

Simple Visual Exam

Use Case for ASHA programme

• In developed markets, Breastlight is a consumer product for home use screening as there is limited scope for use in a clinical setting

• In India, the most effective way to improve the breast screening rate is through Guided Breast Exams (GBEs) especially where mammographic assessment of the population is not routine or feasible

• GBEs can be delivered either at the primary care clinic (Clinical Breast Exam) or through a trained nurse or ASHA worker in the field

• Breastlight is an excellent catalyst to start, sustain and deliver high quality GBE programmes

Salient FeaturesFeatures that make Breastlight suitable for mass screening through Guided Breast

Exams:

• Handheld: Lightweight and portable at 0.7 kg.• User Friendly: Simple visual examination.• Simple Training: Nurses, and Health workers can be easily trained• Cost Effectiveness: Re-usable with rechargeable battery. Battery works

for several hours on a single charge.• Accurate: Sensitivity proven – similar to mammography (please

see Appendix C). Has detected tumours as small as 7mm. The average size of tumour detected by trained practitioners is about 25mm.

• Affordable: Minimal one time investment. • Patient Comfort: Safe, painless with no radiation. Touch sensitive – full

light intensity only on contact with the skin to avoid glare to eyes.

Thank you for your time! Further information, demonstrations and references available on request. Please take a moment to review the appendices for further details.

Parag Agarwal+91 9892504526info@paragise.com

DISCLAIMERWhilst Breastlight is a valuable aid to breast awareness, Breastlight is not capable of detecting all sizes, positions and types of breast abnormalities. It is not intended for use as a diagnostic device.

PWB Health and its associates and distributors makes no claim that breast cancer, breast lumps or other breast diseases will be found when using Breastlight.

Breastlight may highlight a potential abnormality that subsequently turns out to be normal or requires minimal medical intervention. For example blood filled cysts and haemotomas will appear as dark areas. However we would recommend that any suspicious signs are investigated by a doctor.

Breastlight is not suitable for use when breast feeding

Thank You!

The Science• Tumours need their own blood

supply to grow and sustain. This process is called angiogenesis.

• Breastlight transilluminates the breast with a high intensity red light (617nm) which is absorbed by haemoglobin in areas of high vascularity.

• The degree of light absorption is determined by the number of blood cells per unit volume of breast tissue.

• Cysts appear translucent whereas blood filled cysts, haematomas and neoplastic tumours appear opaque, as a dark area or shadow.

APPENDIX A

Clinical Validation

Study Sample Size Malignant Tumours

Breastlight Positive

Detection Rate % (sensitivity)

Breastlight Negative on non-cancers (specificity)

Aberdeen 178 95 69 73% 82%

Sunderland 300 18 12 67% 85% *

Total 478 113 81 72% 84%

* Specificity in non index breast 97%Mammography sensitivity 60-85% & specificity 74-95% ; Kavanagh et alConsolidated results from two trials carried out at the University of Aberdeen, April 1995and City University of Sunderland, December 2009

APPENDIX B

.

Mammography

Mammography Breastlight (Clinical Breast Exam)

Sensitivity 60-85% 72%

Specificity 74-95% 84%

Radiation Exposure Yes No

Patient Comfort Painful Painless

Frequency Once every 1-2 yearsMisses Interval Cancers

Unlimited use – recommended monthly

Breast Density Less effective with denser breasts. Therefore less effective with younger women

Unaffected – suitable for all ages

False positives due to cysts, fibroadenoma, fatty or glandular tissue

Possible No – shines through as light is absorbed only by haeomoglobin

Economics High capital, maintenance and training costs

Affordable, one time investment. Minimal training.

In the context of the use of the device in a clinical setting, under the supervision of a doctor, nurse or trained healthcare worker, it may be useful to highlight the differences and similarities between the two approaches. In 2008 the cost-effectiveness of different screening tools was compared for the Indian context and the authors at National Cancer Insititute US) found that an annual clinical breast exam (CBE) yielded a similar mortality reduction as biennial mammography (23.3% vs. 25.8%) at only half the costs.

APPENDIX C

Testimonials• “My patients have high mammography awareness. I am happy with the product, and will also

recommend to my patients” Dr Soonawala, prominent gynaecologist to celebrities and upper income class patients. He has won the President’s Padma Shree, one of the highest civilian honours.

• “Breastlight works efficiently. Not only does it diagnose early suspicious lesions, it inculcates a

lifestyle in women wherein she is aware of her body and the changes that take place and is not afraid to confront her problems right in the beginning. It’s a shift of mindset which is much required in our country where women tend to ignore their problems and keep them under wraps until its too late sometimes.” Dr Shivani Chaturvedi, Gyneacologist, Agra. A patient of hers was recently diagnosed with breast cancer after spotting a shadow using Breastlight and going for further tests

• "It appears that Breastlight is effective in the detection of malignant tumours and in some cases can differentiate between malignant and benign disease. This device will prove to be of particular value to women who experience difficulty in self examination - for example those with a history of recurrent cysts." Mr Obi Iwuchukwu, Consultant Breast Surgeon, Sunderland City Hospital

• "It appears that this device does not cause unnecessary anxiety, nor is it likely to result in a number of false positives. It could prove useful for younger women who do not benefit from routine mammogram testing and often have more aggressive cancers." Jayant Vaidya, Consultant Breast Surgeon, UCLH

APPENDIX D

Video (click on box to play)

APPENDIX E